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Clinical Trials/NCT04705558
NCT04705558
Unknown
Not Applicable

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

Badr University1 site in 1 country70 target enrollmentJuly 20, 2020
ConditionsPreDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Badr University
Enrollment
70
Locations
1
Primary Endpoint
change in fasting plasma glucose
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 20, 2020
End Date
February 10, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Badr University
Responsible Party
Principal Investigator
Principal Investigator

Mona Mohamed Abdelkhalek

lecturer

Badr University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

change in fasting plasma glucose

Time Frame: 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

Time Frame: 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 Outcomes

  • change in Body composition(three month)

Study Sites (1)

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