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Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight

Primary Purpose

PreDiabetes

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
continuous moderate intensity aerobic training
ketogenic diet
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. female with their age ranged from 40-60 years
  2. body mass index (BMI) from 20-25 kg/m2
  3. fasting serum glucose range 5.6 to 6.9 mmol/L
  4. hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin.

Exclusion criteria:

  1. renal insufficiency
  2. liver disease
  3. abnormal cardiovascular function
  4. diabetes
  5. untreated hypertension
  6. dyslipidemia
  7. abnormal thyroid function
  8. anyone who has undergone gallbladder removal
  9. musculoskeletal constraint preventing them from fully participating in the exercise intervention

Sites / Locations

  • Mona Mohamed AbdelkhalekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group I

group II

Arm Description

Continuous aerobic exercise with ketogenic diet for three month

Ketogenic diet alone for three month

Outcomes

Primary Outcome Measures

change in fasting plasma glucose
Fasting blood specimen was obtained and measured participants' fasting plasma glucose. Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 5.6 - 7.0 mmol/L
change in glycated hemoglobin
Fasting blood specimen was obtained and measured participants' glycated hemoglobin (HbA1c) Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had HbA1c level of 5.7% - 6.4%

Secondary Outcome Measures

change in Body composition
Body Weight was measured in kilograms and Height was measured in meters then body mass index (BMI) was calculated by dividing weight in kilograms on height in meters square BMI = kg/m2 . Waist circumference measurements have been made to the nearest 0.1 centimeter using a tape measure at the uppermost lateral border of the hip crest (ilium)

Full Information

First Posted
January 7, 2021
Last Updated
February 1, 2021
Sponsor
Badr University
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1. Study Identification

Unique Protocol Identification Number
NCT04705558
Brief Title
Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight
Official Title
Combination of Ketogenic Diet and Aerobic Exercise Versus Ketogenic Diet Alone in Prediabetes Female With Normal Weight
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
February 7, 2021 (Anticipated)
Study Completion Date
February 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University

4. Oversight

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

5. Study Description

Brief Summary
Individuals with prediabetes have a high risk of developing type 2 diabetes. The purpose of this study was to compare the effect of combination of ketogenic diet and aerobic exercise interventions versus ketogenic diet alone on the glucose level in prediabetes female with normal weight.
Detailed Description
Pre-diabetes is the preceding condition of diabetes, where the blood sugar level is higher than normal but lower than the diagnostic criteria of type II diabetes and in most of the cases, this ultimately leads to the development type II diabetes. It has been estimated that the number of pre-diabetic cases will increase to more than 470 million people worldwide, and this is understandably a worrying trend . Many studies have been done on diabetes patients. However, little is known about the pre-diabetic conditions. Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 100 - 125 mg/dL, an HbA1c level of 5.7% - 6.4%, or 2-hour plasma glucose level of 140 - 199 mg/dL. Treatment of pre-diabetes and prevention of the development of pre-diabetes to T2DM,through lifestyle intervention mainly includes nutritious dietary and exercises. Combining a ketogenic diet with exercise is a powerful way to reducing insulin resistance, control blood glucose levels and achieve weight loss. As ketogenic diets are nowadays predictable as being useful, there is presently a shortage of research studies examining just how useful the combination of exercise and a ketogenic diet

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet. ketogenic diet alone.
Masking
ParticipantInvestigator
Masking Description
double
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group I
Arm Type
Experimental
Arm Description
Continuous aerobic exercise with ketogenic diet for three month
Arm Title
group II
Arm Type
Experimental
Arm Description
Ketogenic diet alone for three month
Intervention Type
Other
Intervention Name(s)
continuous moderate intensity aerobic training
Intervention Description
continuous moderate intensity aerobic exercises with ketogenic diet group underwent supervised moderate-intensity exercised on a treadmill at 50%-70% of heart rate reserve for three month
Intervention Type
Other
Intervention Name(s)
ketogenic diet
Intervention Description
Ketogenic diet: a low carbohydrate high-fat diet consisted of the following nutrient conformation: 80% fat, 15% protein and 5% carbohydrates, entire daily intake was estimated to be 20-30 g of carbohydrates for three month.
Primary Outcome Measure Information:
Title
change in fasting plasma glucose
Description
Fasting blood specimen was obtained and measured participants' fasting plasma glucose. Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 5.6 - 7.0 mmol/L
Time Frame
three month
Title
change in glycated hemoglobin
Description
Fasting blood specimen was obtained and measured participants' glycated hemoglobin (HbA1c) Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had HbA1c level of 5.7% - 6.4%
Time Frame
three month
Secondary Outcome Measure Information:
Title
change in Body composition
Description
Body Weight was measured in kilograms and Height was measured in meters then body mass index (BMI) was calculated by dividing weight in kilograms on height in meters square BMI = kg/m2 . Waist circumference measurements have been made to the nearest 0.1 centimeter using a tape measure at the uppermost lateral border of the hip crest (ilium)
Time Frame
three month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female with prediabetes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: female with their age ranged from 40-60 years body mass index (BMI) from 20-25 kg/m2 fasting serum glucose range 5.6 to 6.9 mmol/L hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin. Exclusion criteria: renal insufficiency liver disease abnormal cardiovascular function diabetes untreated hypertension dyslipidemia abnormal thyroid function anyone who has undergone gallbladder removal musculoskeletal constraint preventing them from fully participating in the exercise intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Abdelkhalek, lecturer
Phone
002021024056108
Email
3m.sons@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Abdelkhalek, lecturer
Phone
002021024056108
Email
Mona.Abdelkhalek@buc.edu.eg
Facility Information:
Facility Name
Mona Mohamed Abdelkhalek
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Mohamed Abdelkhalek, LECTURER
Phone
002021024056108
Email
3m.sons@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight

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