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

NCT ID: NCT04705558

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-02-10

Brief Summary

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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

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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

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

ketogenic diet alone.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double

Study Groups

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group I

Continuous aerobic exercise with ketogenic diet for three month

Group Type EXPERIMENTAL

continuous moderate intensity aerobic training

Intervention Type OTHER

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 diet

Intervention Type OTHER

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.

group II

Ketogenic diet alone for three month

Group Type EXPERIMENTAL

ketogenic diet

Intervention Type OTHER

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.

Interventions

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continuous 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

Intervention Type OTHER

ketogenic 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mohamed Abdelkhalek

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mona Mohamed Abdelkhalek

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mona Abdelkhalek, lecturer

Role: CONTACT

002021024056108

Mona Abdelkhalek, lecturer

Role: CONTACT

002021024056108

Facility Contacts

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Mona Mohamed Abdelkhalek, LECTURER

Role: primary

002021024056108

Other Identifiers

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KETO , EXERCISE ON PREDIABETES

Identifier Type: -

Identifier Source: org_study_id

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