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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04705558
Enrollment
70
Registered
2021-01-12
Start date
2020-07-20
Completion date
2021-02-10
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreDiabetes

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

Interventions

OTHERcontinuous 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

OTHERketogenic 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.

Sponsors

Badr University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double

Intervention model description

two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet. ketogenic diet alone.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in fasting plasma glucosethree monthFasting 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 hemoglobinthree monthFasting 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

MeasureTime frameDescription
change in Body compositionthree monthBody 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)

Countries

Egypt

Contacts

Primary ContactMona Abdelkhalek, lecturer
3m.sons@gmail.com002021024056108
Backup ContactMona Abdelkhalek, lecturer
Mona.Abdelkhalek@buc.edu.eg002021024056108

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026