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

PreDiabetes Clinical Trial

Official title:

Combination of Ketogenic Diet and Aerobic Exercise Versus Ketogenic Diet Alone in Prediabetes Female With Normal Weight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705558
• Other study ID #: KETO , EXERCISE ON PREDIABETES
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2021
• Source: Badr University
• Contact: Mona Abdelkhalek, lecturer
• Phone: 002021024056108
• Email: 3m.sons[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 10, 2021
• Est. primary completion date: February 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Other:
• continuous moderate intensity aerobic training
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
• ketogenic diet
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.

Locations

Country	Name	City	State
Egypt	Mona Mohamed Abdelkhalek	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three month
Primary	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%	three month
Secondary	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)	three month