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

NCT ID: NCT05925933

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

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

Control Group

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

Group Type OTHER

Intervention

Intervention Type OTHER

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

Interventions

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Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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).

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diabetes Foundation, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Anoop Misra, MD

Role: CONTACT

Phone: 01149101222

Email: [email protected]

Surya Prakash, PhD+Post Doc

Role: CONTACT

Phone: 01141759672

Email: [email protected]

Other Identifiers

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DFI/DST/2023

Identifier Type: -

Identifier Source: org_study_id