PreDiabetesNCT04705558
Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight
A study testing continuous moderate intensity aerobic training and ketogenic diet in people with PreDiabetes, run by Badr University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- PreDiabetes
- What is being tested?
- continuous moderate intensity aerobic training and ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female with their age ranged from 40-60 years
- body mass index (BMI) from 20-25 kg/m2
- fasting serum glucose range 5.6 to 6.9 mmol/L
- hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin.
Who cannot join
- renal insufficiency
- liver disease
- abnormal cardiovascular function
- diabetes
- untreated hypertension
- dyslipidemia
Show all 9Show fewer
- abnormal thyroid function
- anyone who has undergone gallbladder removal
- musculoskeletal constraint preventing them from fully participating in the exercise intervention
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mona Mohamed Abdelkhalek
Cairo
Mona Mohamed Abdelkhalek, LECTURER, 002021024056108, 3m.sons@gmail.com
About this study
Official title: Combination of Ketogenic Diet and Aerobic Exercise Versus Ketogenic Diet Alone in Prediabetes Female With Normal Weight
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
- Conditions
- PreDiabetes
- Being tested
- continuous moderate intensity aerobic training, ketogenic diet
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous moderate intensity aerobic trainingOther
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
ketogenic dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | Continuous aerobic exercise with ketogenic diet for three month Receives: Other: continuous moderate intensity aerobic training; Other: ketogenic diet |
| group II | Experimental | Ketogenic diet alone for three month Receives: Other: ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three month
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%
Measured: 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)
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start20 Jul 2020
- Primary completion7 Feb 2021 (estimated)
- Study completion10 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet. ketogenic diet alone.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Abdelkhalek, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705558
- Sponsor's protocol ID
- KETO , EXERCISE ON PREDIABETES
- Status last verified
- Feb 2021
- First submitted
- 7 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Ketogenic Diet and Aerobic Exercise Versus Ketogenic Diet Alone in Prediabetes Female With Normal Weight
- ClinicalTrials.gov ID
- NCT04705558
- Acronym / sponsor ID
- KETO , EXERCISE ON PREDIABETES
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 7 Feb 2021 (estimated)
- Study completion
- 10 Feb 2021 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet. ketogenic diet alone.
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Other: continuous moderate intensity aerobic training, Other: ketogenic dietContinuous aerobic exercise with ketogenic diet for three month |
| group II | Experimental | Other: ketogenic dietKetogenic diet alone for three month |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female with their age ranged from 40-60 years
- body mass index (BMI) from 20-25 kg/m2
- fasting serum glucose range 5.6 to 6.9 mmol/L
- hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin.
Key exclusion criteria (9 listed)
- renal insufficiency
- liver disease
- abnormal cardiovascular function
- diabetes
- untreated hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous moderate intensity aerobic trainingcontinuous 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 | Other | group I |
| ketogenic dietKetogenic 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. | Other | group I, group II |
Primary outcome
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%
1 secondary outcome
change in Body composition
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous moderate intensity aerobic training and ketogenic diet in people with PreDiabetes, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdelkhalek, lecturer (002021024056108, 3m.sons@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fasting plasma glucose (time frame: three month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.