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
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
June 29, 2023
June 1, 2023
3 years
June 13, 2023
June 22, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (2)
High Protein Diet
EXPERIMENTALHigh 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.
Control Group
OTHEREquicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%)
Interventions
high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.
Eligibility Criteria
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 29, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
June 29, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
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.