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NCT03386331
VDR Gene Polymorphisms and Weight Loss in Non-diabetic Overweight and Obese Subjects
NA trial testing diet and exercise in Overweight in 110 participants. Completed in 30 March 2019.
30 March 2019
Quick facts
| Lead sponsor | Diabetes Foundation, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 110 |
| Start date | 16 March 2016 |
| Primary completion | 30 March 2019 |
| Estimated completion | 30 March 2019 |
| Sites | 1 location across India |
Drugs / interventions tested
- diet and exercise
Conditions studied
- Overweight — all drugs for Overweight →
- Obesity — all drugs for Obesity →
Sponsor
Diabetes Foundation, India
Who can join
Adults 20 to 60, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a six months intervention study in non-diabetic overweight and obese subjects. Subjects will be counseled for weight loss through diet and exercise. Diet and exercise will be recommended as per the regular norms for weight loss (weight loss ≥10% from baseline weight will be considered as a significant loss of weight) for overweight and obese subjects. A sample size of 90 subjects was calculated but assuming a drop out rate of 20%, 110 subjects will be enrolled. Enrolled subjects will be measured at every visit (monthly) for weight, body composition measures of abdominal obesity and skin folds. They would be assessed for compliance with diet and exercise. Detailed analysis of body composition including DXA, biochemical analysis will be performed at enrollment and after six months intervention. Statistical analysis will be performed to find association between measures of body composition for weight loss and genotypes of the VDR polymorphisms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03386331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Currently open trials in the same condition.
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Other Diabetes Foundation, India trials
Trials by the same sponsor.
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- NCT06386939 — Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans v · recruiting
- NCT06386952 — To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03386331 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Diabetes Foundation, India
- Last refreshed: 4 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03386331.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing