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

NCT04705558 | Unknown

• 1 other identifier: KETO , EXERCISE ON PREDIABETES
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (2)

• 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

  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%

  three month

Secondary Outcomes (1)

• change in Body composition

  three month

Study Arms (2)

group I

EXPERIMENTAL

Continuous aerobic exercise with ketogenic diet for three month

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

group II

EXPERIMENTAL

Ketogenic diet alone for three month

Other: ketogenic diet

Interventions

continuous moderate intensity aerobic training 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

group I

ketogenic diet 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 I; group II

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: female with prediabetes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• renal insufficiency
• liver disease
• abnormal cardiovascular function
• diabetes
• untreated hypertension
• dyslipidemia
• abnormal thyroid function
• anyone who has undergone gallbladder removal
• musculoskeletal constraint preventing them from fully participating in the exercise intervention

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Mona Mohamed Abdelkhalek

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Mona Abdelkhalek, lecturer

CONTACT

002021024056108; 3m.sons@gmail.com

Mona Abdelkhalek, lecturer

CONTACT

002021024056108; Mona.Abdelkhalek@buc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

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

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 12, 2021
• Study Start: July 20, 2020
• Primary Completion: February 7, 2021
• Study Completion: February 10, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

EG (1)