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

Not Applicable

• Conditions: PreDiabetes
• Interventions: Other: ketogenic diet; Other: continuous moderate intensity aerobic training

• Registration Number: NCT04705558
• Lead Sponsor: Badr University

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

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-09
• Study First Posted: 2021-01-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-02-07
• Study Completion: 2021-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group II	ketogenic diet	Ketogenic diet alone for three month
group I	ketogenic diet	Continuous aerobic exercise with ketogenic diet for three month
group I	continuous moderate intensity aerobic training	Continuous aerobic exercise with ketogenic diet for three month

Primary Outcome Measures

Name	Time	Method
change in fasting plasma glucose	three month	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	three month	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

Name	Time	Method
change in Body composition	three month	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)

Trial Locations

Locations (1)

Mona Mohamed Abdelkhalek; 🇪🇬 Cairo, Egypt