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Status unknownNCT04705558Updated Feb 2, 2021

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

An interventional study of continuous moderate intensity aerobic training and ketogenic diet in PreDiabetes, sponsored by Badr University. Status unknown at 1 site in Egypt. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Badr University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2020, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 70 is close to the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Badr University is the lead sponsor of 60 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    group I

    Continuous aerobic exercise with ketogenic diet for three month

    Other: continuous moderate intensity aerobic training · Other: ketogenic diet

  • Experimental
    group II

    Ketogenic diet alone for three month

    Other: 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: three month

  2. 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%

    Time frame: three month

Secondary outcomes

  1. 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)

    Time frame: three month

07

Study locations

1 of 1 sites recruiting
  • Mona Mohamed Abdelkhalek
    Cairo, Egypt
    • Mona Mohamed Abdelkhalek, LECTURER · Contact · 3m.sons@gmail.com · 002021024056108
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04705558
Lead sponsor
Badr University
Responsible party
Mona Mohamed Abdelkhalek (lecturer, Badr University) — Principal investigator
First posted
Jan 12, 2021
Start date
Jul 20, 2020
Primary completion
Feb 7, 2021 (estimated)
Completion
Feb 10, 2021 (estimated)
Last update
Feb 2, 2021

Study contacts

Mona Abdelkhalek, lecturer
Contact
3m.sons@gmail.com
002021024056108
Mona Abdelkhalek, lecturer
Contact
Mona.Abdelkhalek@buc.edu.eg
002021024056108

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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