Clinical trial NCT04705558: 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
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet.

ketogenic diet alone.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change in fasting plasma glucose
timeFrame: three month
measure: change in glycated hemoglobin
timeFrame: three month
Secondary outcomes:
measure: change in Body composition
timeFrame: three month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mona Mohamed Abdelkhalek
Study officials:
References: