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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-diabetes
• Intervention / Treatment: Other: Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anoop Misra, MD; Phone Number: 01149101222; Email: anoopmisra@gmail.com
• Study Contact Backup: Name: Surya Prakash, PhD+Post Doc; Phone Number: 01141759672; Email: suryabhat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Protein Diet; 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.	Other: Intervention; high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.
Other: Control Group; Equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%)	Other: Intervention; high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: DFI/DST/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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 or high protein diet over 8-week periods. All assessments as done on day 1 will be repeated on day 60.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No