Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05925933

High Protein Diet on Transcriptomic, 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention

Other

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

Primary outcomes

  1. Body Mass Index

    Time frame: 6 Months

    BMI will be calculated by using formula weight (Kg)/height (m2).

  2. Body Fat

    Time frame: 2 MONTHS

    Body estimations will be done by DEXA Scan

  3. Liver Fat

    Time frame: 2 Months

    Liver fat will be done by MRI Scan

  4. Next Generation sequencing

    Time frame: 06 MONTHS

  5. Pancreatic fat

    Time frame: 06 MONTHS

    Pancreatic fat estimation will be done by MRI

  6. RNA Extraction

    Time frame: 06 MONTHS

  7. Metabolomics profile

    Time frame: 06 MONTHS

Study contacts

Contact information is provided by the study sponsor or research team.

Anoop Misra, MD

CONTACT

[email protected]

01149101222

Surya Prakash, PhD+Post Doc

CONTACT

[email protected]

01141759672

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.