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

Pre-diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05925933
• Other study ID #: DFI/DST/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: June 2023
• Source: Diabetes Foundation, India
• Contact: Anoop Misra, MD
• Phone: 01149101222
• Email: anoopmisra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 31, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Intervention
high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diabetes Foundation, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	BMI will be calculated by using formula weight (Kg)/height (m2).	6 Months
Primary	Body Fat	Body estimations will be done by DEXA Scan	2 MONTHS
Primary	Liver Fat	Liver fat will be done by MRI Scan	2 Months
Primary	Next Generation sequencing		06 MONTHS
Primary	Pancreatic fat	Pancreatic fat estimation will be done by MRI	06 MONTHS
Primary	RNA Extraction		06 MONTHS
Primary	Metabolomics profile		06 MONTHS