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Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
10-week exercise programme based on aerobic interval and resistance training
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Obese, Non-obese, Qatar

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. New onset T2DM (<5 years duration).
  2. Aged 18 and 60 years.
  3. Residents of Qatar with intention to stay for the duration of the study (approx 4 months)
  4. Otherwise healthy or with stable, treated medical conditions (hypertension, hyperlipidemia, hypothyroidism, etc.)
  5. Hemoglobin A1c (HbA1c) level < 8%.
  6. "Diet and lifestyle" or metformin or DPP4 inhibitors prescribed for T2DM.
  7. Willingness and ability to comply with the exercise protocol and study duration.

Exclusion Criteria:

  1. Type 1 Diabetes Mellitus or history of hospitalization for hyperglycemia or suspected ketoacidosis.
  2. T2DM prescribed insulin, or any other anti-diabetic agent other than metformin or DDP4 inhibitors.
  3. HbA1c ≥8.0%.
  4. Body mass index (BMI) ≤ 18.5 kg/m2 (underweight) and ≥ 40 kg/m2 (morbid obese).
  5. Reported weight loss or gain (± 2 kg) over the preceding three months;
  6. Pregnant or lactating women or women planning to be pregnant during the course of the study.
  7. History of regular exercise (the equivalent of 150 minutes of moderate intensity aerobic and/or 2 sessions of resistance training per week) or of a job that demands a similar degree of physical activity within the past 6 months.
  8. Use of medications that affect glucose metabolism, glucose tolerance or body weight including oral corticosteroids and atypical anti-psychotics.
  9. History of cardiovascular disease including previous myocardial infarction, congestive cardiac failure, valvular heart disease, stroke or the use of medication to alter coagulation including daily aspirin, anti-platelet drugs or any class of anticoagulant or a clinically significant abnormality on electrocardiogram that in the opinion of a consulting cardiologist should prevent participation.
  10. History of chronic diseases associated with inflammation and/or the daily use of anti-inflammatory or immunosuppressant medications for arthritis, gout, rheumatologic disorders, inflammatory bowel disease, or viral infections including hepatitis B, C and HIV.
  11. History of psychiatric disorders including current clinical depression, schizophrenia, bipolar disorder or subjects with known claustrophobia.
  12. History of chronic neurological disorders such as epilepsy, dementia or movement disorders.
  13. Hematocrit <33%.
  14. Participation in other research studies that require blood drawing or any medical, nutritional or behavioral intervention.
  15. The presence of large ferromagnetic tattoos that may interfere with the MRI determination of body fat.

Sites / Locations

  • Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-obese Qatar residents with type 2 diabetes

Obese Qatar residents with type 2 diabetes

Arm Description

Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >18.5 and <30.0 kg/m2

Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >30.0 to <40.0 kg/m2

Outcomes

Primary Outcome Measures

Insulin sensitivity
Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure.

Secondary Outcome Measures

Glucose regulation/ insulin sensitivity
Glucose regulation and insulin sensitivity will be assessed via a 4-hour Oral glucose tolerance test procedure.
Pancreatic beta-cell function
Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.
Hepatic insulin resistance index
The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure.
Vascular reactivity
Endothelial reactivity will be assessed during the euglycemic clamp procedure, using an standard blood pressure arm cuff and the VENDYS instrument.
Body Mass Index (BMI)
Patient's weight and height will be measured in kilograms (kg) and meters (m), respectively, and combined to report BMI in kg/m^2
Body fat profiling
Mesenteric, hepatic, subcutaneous and skeletal muscle infiltrating fat will be measured with a 3.0T MR-scanner using a whole-body Dixon protocol. Hepatic fat content and skeletal muscle fat infiltration will be measured. All measurements will be performed with 3T Phillips Ingenia scanner.
Total body fat
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive total body fat.
Non-fat mass
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive non-fat mass.
Visceral adipose volume
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive estimates of visceral adipose volume.
Cardiorespiratory fitness (estimated maximal oxygen uptake)
Maximal oxygen uptake (VO2max) will be estimated using the Astrand and Rhyming cycle ergometer protocol.
Upper body strength
Upper body strength will be determined via handgrip strength using a handgrip dynanmometer. Assessments will be conducted on both hands.
Physical function
Physical function will be measured using the 6-minute walk test.
Lower body strength
Lower body strength will be assessed using the 30-s sit to stand test.
Fasting Plasma glucose
The number of particiapnts that have improvement in fasting plasma glucose.

Full Information

First Posted
July 24, 2019
Last Updated
October 3, 2019
Sponsor
Hamad Medical Corporation
Collaborators
Hamad Bin Khalifa University
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1. Study Identification

Unique Protocol Identification Number
NCT04081064
Brief Title
Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar
Official Title
Exploring the Impact of Body Fat Profile, and a Physical Exercise Intervention on Clinical, Metabolic and Molecular Parameters in Qatar Residents With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
Collaborators
Hamad Bin Khalifa 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 prevalence of type 2 diabetes (T2DM) is increasing sharply around the world and obesity and sedentary lifestyles are driving the epidemic. Obesity is often, but not always present in patients with T2DM. The primary aim of this study is to understand the impact of the ratio of lean body mass (metabolically active skeletal muscle) to adipose tissue mass on the severity of insulin resistance and pancreatic beta cell dysfunction in non-obese and obese Qatar residents with T2DM. An exercise programme aimed to increase lean mass and aerobic capacity will be initiated for a period 10 weeks in non-obese and obese early onset diabetics who are residents of Qatar. The effect of the exercise programme on total body fat, regional fat distribution and intramuscular and intrahepatic fat content using magnetic resonance imaging (MRI) in these groups of diabetics will be assessed and related to total body insulin sensitivity and β-cell function as measured with the gold standard methods: the euglycemic clamp technique and arginine stimulation. Genetic approaches including candidate gene testing and non-targeted miRNA expression profiling and metabolomics are employed. Physical fitness pre- and post-intervention will also be assessed. The impact of the exercise programme on conventional inflammatory markers, the phenotype of immune cells, metabolic hormones, and markers of oxidative stress, endoplasmic reticulum stress and heat shock response (Hsp-72, Hsp -40/DNAJB3 and Hsp-25) are studied in relation to metabolic changes. Through this study, the contributions of fitness, fatness and exercise training on insulin resistance and beta cell function will be elucidated in Qatari residents with T2DM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Obese, Non-obese, Qatar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-obese Qatar residents with type 2 diabetes
Arm Type
Experimental
Arm Description
Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >18.5 and <30.0 kg/m2
Arm Title
Obese Qatar residents with type 2 diabetes
Arm Type
Experimental
Arm Description
Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >30.0 to <40.0 kg/m2
Intervention Type
Behavioral
Intervention Name(s)
10-week exercise programme based on aerobic interval and resistance training
Intervention Description
The intervention will take place over 10 weeks. Participants will complete three sessions per week; each sessions will be scheduled at least 24 hours apart. Two sessions per week will consist of aerobic interval exercise and resistance training, and one session per week will consist of aerobic interval exercise only.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Glucose regulation/ insulin sensitivity
Description
Glucose regulation and insulin sensitivity will be assessed via a 4-hour Oral glucose tolerance test procedure.
Time Frame
10 weeks
Title
Pancreatic beta-cell function
Description
Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.
Time Frame
10 weeks
Title
Hepatic insulin resistance index
Description
The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure.
Time Frame
10 weeks
Title
Vascular reactivity
Description
Endothelial reactivity will be assessed during the euglycemic clamp procedure, using an standard blood pressure arm cuff and the VENDYS instrument.
Time Frame
10 weeks
Title
Body Mass Index (BMI)
Description
Patient's weight and height will be measured in kilograms (kg) and meters (m), respectively, and combined to report BMI in kg/m^2
Time Frame
10 weeks
Title
Body fat profiling
Description
Mesenteric, hepatic, subcutaneous and skeletal muscle infiltrating fat will be measured with a 3.0T MR-scanner using a whole-body Dixon protocol. Hepatic fat content and skeletal muscle fat infiltration will be measured. All measurements will be performed with 3T Phillips Ingenia scanner.
Time Frame
10 weeks
Title
Total body fat
Description
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive total body fat.
Time Frame
10 weeks
Title
Non-fat mass
Description
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive non-fat mass.
Time Frame
10 weeks
Title
Visceral adipose volume
Description
Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive estimates of visceral adipose volume.
Time Frame
10 weeks
Title
Cardiorespiratory fitness (estimated maximal oxygen uptake)
Description
Maximal oxygen uptake (VO2max) will be estimated using the Astrand and Rhyming cycle ergometer protocol.
Time Frame
10 weeks
Title
Upper body strength
Description
Upper body strength will be determined via handgrip strength using a handgrip dynanmometer. Assessments will be conducted on both hands.
Time Frame
10 weeks
Title
Physical function
Description
Physical function will be measured using the 6-minute walk test.
Time Frame
10 weeks
Title
Lower body strength
Description
Lower body strength will be assessed using the 30-s sit to stand test.
Time Frame
10 weeks
Title
Fasting Plasma glucose
Description
The number of particiapnts that have improvement in fasting plasma glucose.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Heart rate during exercise sessions
Description
Heart rate will be recorded using polar H10 monitors and the polar team system throughout exercise programme.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New onset T2DM (<5 years duration). Aged 18 and 60 years. Residents of Qatar with intention to stay for the duration of the study (approx 4 months) Otherwise healthy or with stable, treated medical conditions (hypertension, hyperlipidemia, hypothyroidism, etc.) Hemoglobin A1c (HbA1c) level < 8%. "Diet and lifestyle" or metformin or DPP4 inhibitors prescribed for T2DM. Willingness and ability to comply with the exercise protocol and study duration. Exclusion Criteria: Type 1 Diabetes Mellitus or history of hospitalization for hyperglycemia or suspected ketoacidosis. T2DM prescribed insulin, or any other anti-diabetic agent other than metformin or DDP4 inhibitors. HbA1c ≥8.0%. Body mass index (BMI) ≤ 18.5 kg/m2 (underweight) and ≥ 40 kg/m2 (morbid obese). Reported weight loss or gain (± 2 kg) over the preceding three months; Pregnant or lactating women or women planning to be pregnant during the course of the study. History of regular exercise (the equivalent of 150 minutes of moderate intensity aerobic and/or 2 sessions of resistance training per week) or of a job that demands a similar degree of physical activity within the past 6 months. Use of medications that affect glucose metabolism, glucose tolerance or body weight including oral corticosteroids and atypical anti-psychotics. History of cardiovascular disease including previous myocardial infarction, congestive cardiac failure, valvular heart disease, stroke or the use of medication to alter coagulation including daily aspirin, anti-platelet drugs or any class of anticoagulant or a clinically significant abnormality on electrocardiogram that in the opinion of a consulting cardiologist should prevent participation. History of chronic diseases associated with inflammation and/or the daily use of anti-inflammatory or immunosuppressant medications for arthritis, gout, rheumatologic disorders, inflammatory bowel disease, or viral infections including hepatitis B, C and HIV. History of psychiatric disorders including current clinical depression, schizophrenia, bipolar disorder or subjects with known claustrophobia. History of chronic neurological disorders such as epilepsy, dementia or movement disorders. Hematocrit <33%. Participation in other research studies that require blood drawing or any medical, nutritional or behavioral intervention. The presence of large ferromagnetic tattoos that may interfere with the MRI determination of body fat.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica C Skarulis, MD
Phone
974 50013990
Email
myoung@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahem Abdalhakam, MD
Phone
974 40254991
Email
ibrahemabdalhakam1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica C Skarulis, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
PO BOX 3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica C Skarulis, MD
Phone
974 44392734
Email
myoung@hamad.qa
First Name & Middle Initial & Last Name & Degree
Ibrahem Adalhakam, MD
Phone
974 44390969
Email
ibrahemabdalhakam1@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar

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