High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes

Diabetes Foundation, India

Status: Not yet enrolling

Conditions: Pre-diabetes

Treatments: Other: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05925933

DFI/DST/2023

Details and patient eligibility

About

Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.

Full description

This study will be conducted at the outpatient department of the National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI)and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.

Experimental Protocol: In this study, a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender-matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) or a high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated at day 60.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Acute infections and advanced end-organ damage.
• History of hepatitis or pancreatitis, abnormal liver and renal function tests.
• Recent (<3 months) changes in weight (≥5%) and/or weight changing medications.
• Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.

Inclusion Criteria

Cases:

• Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)
• Fasting blood glucose≥100mg/dl and <126 mg/dl or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 grams of anhydrous oral glucose) or both.

Controls:

• Age 18 to 50 years. Normoglycemia by OGTT
• Fasting blood glucose <100mg/dl and 2-h plasma glucose <140mg/dl (after ingestion of 75 gram of anhydrous oral glucose).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

High Protein Diet

Experimental group

Description:

High protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated on day 60.

Treatment:

Other: Intervention

Control Group

Other group

Description:

Equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%)

Treatment:

Other: Intervention