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
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.
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Diabetes Foundation, India |
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 |
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