NCT07918170Not yet recruiting
LEANDIP: Lean Diabetes in Asian Indians
Lean Diabetes in Asian Indians: An Integrated Genomic, Metabolomic and Pancreatic Imaging Phenotyping Study With Longitudinal Clinical Progression (LEANDIP)
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
LEANDIP is a multicentric, prospective comparative longitudinal phenotyping study designed to characterize lean diabetes (BMI <19 kg/m²) in Asian Indians and determine whether it represents a distinct metabolic and biological phenotype. Study population: 151 participants - Lean diabetes (n=75), healthy lean controls (n=38), and non-lean/classical T2D (n=38). Baseline phenotyping: Clinical and anthropometric assessment, biochemical investigations, insulin/C-peptide assessment with MMTT, body composition by DEXA, and assessment of diabetes-related complications where applicable. Advanced phenotyping: MRI-PDFF for pancreatic, hepatic and abdominal fat; genomic analysis in lean diabetes and healthy lean controls; and metabolomics in predefined subsets. Comparative objective: To identify clinical, metabolic, body-composition, imaging, genomic and metabolomic characteristics specific to lean diabetes compared with healthy leanness and classical T2D. Longitudinal component: Lean diabetes participants will be followed at 6 and 12 months to assess glycaemic progression, complications, treatment requirements and changes in phenotype. Overall aim: To improve understanding of the biological basis, pancreatic dysfunction, ectopic fat phenotype and clinical progression of lean diabetes in Asian Indians, potentially enabling better identification and management of this under-recognized phenotype.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 151 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Diabetes Foundation, India
- Diseases
- Type 2 diabetes
- NCT number
- NCT07918170
What you commit to
- Study type: Observational
- Planned participants: 151
- From 1 Nov 2026 to the primary completion date, 30 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Proven Type 1 diabetes Monogenic diabetes Lipodystrophies, Mitochondrial diabetes Secondary diabetes (chronic calcific pancreatitis, pancreatectomy, steroid induced diabetes) Seriously ill patient Patients with history of acute myocardial infarction, advanced renal failure and liver disease tuberculosis, carcinoma, malabsorptionsyndrome, hyperthyroidism, HIV or any severe infection.
Other
- Pregnant or lactating women
Who the study is looking for
- Group 1- Lean Diabetes:
- BMI <19 kg/m²
- Age 18-50 years
- Newly diagnosed, treatment-naive diabetes according to ADA criteria
- Group 2- Healthy lean without diabetes:
- BMI <19 kg/m²
- Age 18-50 years
- No history of diabetes and normal glycemic status (FPG, HbA1c and/or OGTT as per ADA criteria)
- Group 3- Non-lean T2D:
- BMI >19 kg/m²
- Age 18-50 years
- Diabetes according to ADA criteria All the participants willing to provide written informed consent
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.