search
Back to results

Effects of Exercise Based Manual in Sedentary Prediabetic Population

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exercise Based Manual (Supervised)
Exercise Based Manual (Home Based)
Control
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Prediabetic, Exercise intervention, Biochemical parameters, Cardiorespiratory parameters, Physical parameters

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Serum glucose test indicating prediabetic (HbA1c level of 5.7% - 6.4% or fasting plasma glucose of 100 - 12
  • Sedentary Subjects (<150 min/week or <600 MET-min/week on IPAQ Urdu Version)

Exclusion Criteria:•

  • History of type 2 diabetes mellitus or newly diagnosed diabetes within last 6 months
  • BMI under 18.5 and more 30
  • Persons involve in other weight management program,
  • History of taking any herbal medications to control the weight
  • Clinical history of cardiovascular diseases occurred within the past six months
  • Pregnancy

Sites / Locations

  • Riphah Rehabiliation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental: Exercise Based Manual (Supervised)

Experimental: Exercise Based Manual (Home Based)

Placebo Comparator: Control

Arm Description

Supervised Exercises with exercise based Manual (exercise & Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of different type of exercises including warm up and rest interval

Experimental: Exercise Based Manual (Home Based) Home Based- Exercise Manual (Exercise & Educational Component) for 16 weeks. Subject will be asked to maintain a regular exercise.

Age matched Control Group followed for 16 weeks with General Advise to active

Outcomes

Primary Outcome Measures

Hemoglobin A1c Test (HbA1C0
Hemoglobin A1c Test tells you average level of blood sugar over the past 2 to 3 months.The normal range for the hemoglobin A1c level is between 4% and 5.6% and readings will be taken at baseline,8th week and 16 week.
Fasting blood Glucose(FBG)
This test checks your fasting blood sugar levels. Fasting means after not having anything to eat or drink (except water) for at least 8 hours before the test. Normal value will be less than 100 mg/dl and Prediabetes value 100 mg/dl to 125 mg/dl.Reading will be taken after 8 hour fasting. Readings will be taken at baseline,8th week and 16 week
Homeostasis model assessment of β-cell function(HOMA-β)
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations.It is calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).Sample will be taken from intravenous blood sample & readings will be taken at baseline and at 16 weeks.
Homeostatic Model Assessment for Insulin Resistance(HOMA-IR)
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. Healthy Range: 1.0 (0.5-1.4).Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. sample will be taken from intravenous blood sample & readings will be taken at baseline and at 16 weeks.
low-density lipoproteins(LDL)
low-density lipoproteins sometimes called the "bad" cholesterol Value Less than 100mg/dL is Optimal, value 100-129mg/dL Near optimal/above optimal,Value 130-159 mg/dL Borderline high. Reading will be taken at baseline,8th week and at 16 weeks of intervention.
high-density lipoproteins( HDL)
high-density lipoproteins sometimes called the "good" cholesterol.HDL that falls within the range of 40 to 59 mg/dL is normal. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Triglycerides
Triglycerides are a type of fat (lipid) found in your blood. Normal triglyceride levels in the blood are less than 150 mg per deciliter (mg/dL). Readings will be taken at baseline,8th week and 16 weeks of intervention.
Maximal oxygen consumption( VO2max)
the maximum or optimum rate at which the heart, lungs, and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.A good VO2 max for a male is 42.5-46.4 mL/kg/min, while a good value for a female is 33.0-36.9 mL/kg/min.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Rate of perceived exertion( PRE)
The RPE scale is used to measure the intensity of your exercise. The RPE scale runs from 0 - 10. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Baseline Dyspnea Index(BDI)
Baseline Dyspnea Index (BDI) measures the severity of dyspnea at the baseline Readings will be taken at baseline,8th week and 16 weeks of intervention.
weight in kilograms
Weight (symbolized w ) is a quantity representing the force exerted on a particle or object by an acceleration field, particularly the gravitational field of the Earth at the surface.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Body mass index (BMI)
is a measure of body fat based on height and weight that applies to adult men and women. Below 18.5 is Underweight,18.5-24.9 is Normal,25.0-29.9 is Overweight, 30.0 and Above is Obese. Readings will be taken at baseline,8th week and 16 weeks of intervention.
waist circumference
Waist circumference is the measurement taken around the abdomen at the level of the umbilicus (belly button). For best health, waist should be less than 40 inches around for men, and less than 35 inches for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
waist to hip ratio (WHR)
Waist too hip ratio is a quick measure of fat distribution that may help indicate a person's overall health. A healthy WHR is: 0.9 or less in men. 0.85 or less for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Body fat percentage
body fat percentage as just one way to assess and monitor your weight and overall body composition.Men Women Average value for men is18%-24% and foe women is 25%-31%.Value for Obese men is 25% and higher, for obese women is 32% and higher. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of body fat analyzer.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2021
Last Updated
October 11, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT04949958
Brief Title
Effects of Exercise Based Manual in Sedentary Prediabetic Population
Official Title
Effects of Exercise Based Manual on Biochemical, Cardiorespiratory and Physical Parameters in Sedentary Prediabetic Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The prediabetes is a state in which fasting blood glucose level ranges between 100-126mg/dl or HbA1C ranges between 5.7-6.4mmol. People with prediabetes have 74 percent chance of progression to develop Type 2 diabetes mellitus. However, by lifestyle intervention, Type 2 Diabetes mellitus may be effectively avoided or delayed. The improvement in lifestyle is involving the physical activity of at least 150mins per week lowered the rate of T2DM in people with prediabetes by 58 percent. There are several risk factors for the development of type 2 diabetes mellitus, but obesity and lack of physical activity are major risk factors that cause type 2 diabetes mellitus in prediabetic populations. Diet and exercise are the first line treatment for sedentary prediabetics. Both independent and combined effect of diet and exercise can reduce the incidence of T2DM, glycemic control and weight loss in adults with prediabetics
Detailed Description
The most alarming public health issues of the 21st century is epidemic of diabetes especially in lower middle-income countries. There will be a 67 percent raise in prevalence of diabetes from 2010 to 2030 .With up to half of deaths occurring in people under the age of 60 is due to diabetes as T2DM is among the top ten causes of death.According to American Diabetic Association, if Fasting blood glucose level falls between <100mg/dl or HbA1C falls between <5.7% then person has normal blood sugar level if Fasting blood glucose level falls between 100-125mg/dl or HbA1C falls between 5.7%-6.4% then person is diagnosed as prediabetic and if value of fasting blood glucose level falls between 126-200mg/dl and HbA1C more than 6.5% then person is diagnose as Type 2 Diabetes mellitus. Prediabetes is a state in which the body can maintain blood glucose level but impaired insulin sensitivity is still present.Worldwide there is a 74 percent chance of progression of prediabetes into Type 2 Diabetes Mellitus. Strategies for prevention of T2DM are highly recommended for sedentary population.There are now estimated 38 million adults living with diabetes around the world. The main cause of premature death in the world with ration of every 6 into 10 due to the effects of diabetes and diabetes-related complications. Pakistan is now in the top 10 countries with increase in the incidence of diabetes. According to WHO, around 19 million people are diagnosed with diabetes and 10 million people are diagnosed as prediabetics. An estimated 463 million adults worldwide live with diabetes and 55 million live with prediabetes. However there are some risk factors for T2DM that can be modifiable including obesity, metabolic syndrome characteristics (abdominal obesity, elevated triglycerides, low density lipoprotein), high blood pressure and elevated plasma glucose, insulin resistance, sedentary lifestyle Exercise intervention requires repetitive body movements performed to enhance or sustain one or more physical fitness components such as aerobic ability, muscle strength and endurance, flexibility. Sedentary lifestyle is associated with an increased risk of death, cardiovascular disease and increase the incidence of T2DM which is mostly recognized in young adult population.Physical exercise facilitates improved functioning of the human body. Regular exercise enhances insulin sensitivity thus helping to avoid diabetes.Exercise training is known to increase the absorption of insulin-mediated skeletal muscle glucose and blood flow to limbs thus leading to reduction in glycemic control in diabetic population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Prediabetic, Exercise intervention, Biochemical parameters, Cardiorespiratory parameters, Physical parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Exercise Based Manual (Supervised) Supervised exercise based Manual (exercise & Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of combination of different exercises including warm up and rest interval Experimental: Exercise Based Manual (Home Based) Home Based- Exercise Manual (Exercise & Educational Component) for 16 weeks. Subject will be asked to maintain a regular exercise and dietary education to ensure adherence to the program Placebo Comparator: Control Age matched Control Group followed for 16 weeks with General Advise to be active.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple Blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Exercise Based Manual (Supervised)
Arm Type
Experimental
Arm Description
Supervised Exercises with exercise based Manual (exercise & Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of different type of exercises including warm up and rest interval
Arm Title
Experimental: Exercise Based Manual (Home Based)
Arm Type
Experimental
Arm Description
Experimental: Exercise Based Manual (Home Based) Home Based- Exercise Manual (Exercise & Educational Component) for 16 weeks. Subject will be asked to maintain a regular exercise.
Arm Title
Placebo Comparator: Control
Arm Type
Placebo Comparator
Arm Description
Age matched Control Group followed for 16 weeks with General Advise to active
Intervention Type
Other
Intervention Name(s)
Exercise Based Manual (Supervised)
Intervention Description
Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise, Exercise and Education. The exercise will be supervised while other component will be home based.
Intervention Type
Other
Intervention Name(s)
Exercise Based Manual (Home Based)
Intervention Description
Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise and Education. All two components will be home based.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
General advice to be active
Primary Outcome Measure Information:
Title
Hemoglobin A1c Test (HbA1C0
Description
Hemoglobin A1c Test tells you average level of blood sugar over the past 2 to 3 months.The normal range for the hemoglobin A1c level is between 4% and 5.6% and readings will be taken at baseline,8th week and 16 week.
Time Frame
16 week
Title
Fasting blood Glucose(FBG)
Description
This test checks your fasting blood sugar levels. Fasting means after not having anything to eat or drink (except water) for at least 8 hours before the test. Normal value will be less than 100 mg/dl and Prediabetes value 100 mg/dl to 125 mg/dl.Reading will be taken after 8 hour fasting. Readings will be taken at baseline,8th week and 16 week
Time Frame
16 weeks
Title
Homeostasis model assessment of β-cell function(HOMA-β)
Description
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations.It is calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).Sample will be taken from intravenous blood sample & readings will be taken at baseline and at 16 weeks.
Time Frame
16 weeks
Title
Homeostatic Model Assessment for Insulin Resistance(HOMA-IR)
Description
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. Healthy Range: 1.0 (0.5-1.4).Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. sample will be taken from intravenous blood sample & readings will be taken at baseline and at 16 weeks.
Time Frame
16 weeks
Title
low-density lipoproteins(LDL)
Description
low-density lipoproteins sometimes called the "bad" cholesterol Value Less than 100mg/dL is Optimal, value 100-129mg/dL Near optimal/above optimal,Value 130-159 mg/dL Borderline high. Reading will be taken at baseline,8th week and at 16 weeks of intervention.
Time Frame
16 weeks
Title
high-density lipoproteins( HDL)
Description
high-density lipoproteins sometimes called the "good" cholesterol.HDL that falls within the range of 40 to 59 mg/dL is normal. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
Triglycerides
Description
Triglycerides are a type of fat (lipid) found in your blood. Normal triglyceride levels in the blood are less than 150 mg per deciliter (mg/dL). Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
Maximal oxygen consumption( VO2max)
Description
the maximum or optimum rate at which the heart, lungs, and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.A good VO2 max for a male is 42.5-46.4 mL/kg/min, while a good value for a female is 33.0-36.9 mL/kg/min.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
Rate of perceived exertion( PRE)
Description
The RPE scale is used to measure the intensity of your exercise. The RPE scale runs from 0 - 10. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
Baseline Dyspnea Index(BDI)
Description
Baseline Dyspnea Index (BDI) measures the severity of dyspnea at the baseline Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
weight in kilograms
Description
Weight (symbolized w ) is a quantity representing the force exerted on a particle or object by an acceleration field, particularly the gravitational field of the Earth at the surface.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
Body mass index (BMI)
Description
is a measure of body fat based on height and weight that applies to adult men and women. Below 18.5 is Underweight,18.5-24.9 is Normal,25.0-29.9 is Overweight, 30.0 and Above is Obese. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Time Frame
16 weeks
Title
waist circumference
Description
Waist circumference is the measurement taken around the abdomen at the level of the umbilicus (belly button). For best health, waist should be less than 40 inches around for men, and less than 35 inches for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Time Frame
16 weeks
Title
waist to hip ratio (WHR)
Description
Waist too hip ratio is a quick measure of fat distribution that may help indicate a person's overall health. A healthy WHR is: 0.9 or less in men. 0.85 or less for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Time Frame
16 weeks
Title
Body fat percentage
Description
body fat percentage as just one way to assess and monitor your weight and overall body composition.Men Women Average value for men is18%-24% and foe women is 25%-31%.Value for Obese men is 25% and higher, for obese women is 32% and higher. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of body fat analyzer.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Serum glucose test indicating prediabetic (HbA1c level of 5.7% - 6.4% or fasting plasma glucose of 100 - 12 Sedentary Subjects (<150 min/week or <600 MET-min/week on IPAQ Urdu Version) Exclusion Criteria:• History of type 2 diabetes mellitus or newly diagnosed diabetes within last 6 months BMI under 18.5 and more 30 Persons involve in other weight management program, History of taking any herbal medications to control the weight Clinical history of cardiovascular diseases occurred within the past six months Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Hafeez, PhD*
Phone
92331-4545667
Email
sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Shakil ur Rehman, PhD
Phone
92 320 7866611
Email
shakil.urrehman@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah Rehabiliation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Hafeez, PhD*
Phone
92331-4545667
Email
sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sana Hafeez, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27776003
Citation
Rowan CP, Riddell MC, Gledhill N, Jamnik VK. Aerobic Exercise Training Modalities and Prediabetes Risk Reduction. Med Sci Sports Exerc. 2017 Mar;49(3):403-412. doi: 10.1249/MSS.0000000000001135.
Results Reference
background
PubMed Identifier
30064689
Citation
Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Corrigendum to 'Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods☆'' [Contemp. Clin. Trials 54 (2017) 68-76]. Contemp Clin Trials. 2018 Aug;71:205. doi: 10.1016/j.cct.2018.06.014. Epub 2018 Jul 7. No abstract available.
Results Reference
background
PubMed Identifier
24423095
Citation
Aguiar EJ, Morgan PJ, Collins CE, Plotnikoff RC, Callister R. Efficacy of interventions that include diet, aerobic and resistance training components for type 2 diabetes prevention: a systematic review with meta-analysis. Int J Behav Nutr Phys Act. 2014 Jan 15;11:2. doi: 10.1186/1479-5868-11-2.
Results Reference
background
PubMed Identifier
23032182
Citation
Barengo NC, Tuomilehto J. Diabetes: exercise benefits in type 2 diabetes mellitus. Nat Rev Endocrinol. 2012 Nov;8(11):635-6. doi: 10.1038/nrendo.2012.182. Epub 2012 Oct 2. No abstract available.
Results Reference
background
PubMed Identifier
30273708
Citation
Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
Results Reference
background
PubMed Identifier
24239920
Citation
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.
Results Reference
background
PubMed Identifier
15649575
Citation
Kosaka K, Noda M, Kuzuya T. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Diabetes Res Clin Pract. 2005 Feb;67(2):152-62. doi: 10.1016/j.diabres.2004.06.010.
Results Reference
background
PubMed Identifier
9096977
Citation
Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
Results Reference
background
PubMed Identifier
22187469
Citation
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
Results Reference
background

Learn more about this trial

Effects of Exercise Based Manual in Sedentary Prediabetic Population

We'll reach out to this number within 24 hrs