VDR Gene Polymorphisms and Weight Loss in Non-diabetic Overweight and Obese Subjects

NCT03386331 | Completed

• 1 other identifier: 5/4/8-9/11/NCDII
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight (Kg)

  weight loss

  6 months

Secondary Outcomes (1)

• Genetic polymorphism

  6 months

Study Arms (1)

Diet and Exercise

OTHER

Behavioral: diet and exercise

Interventions

diet and exercise BEHAVIORAL

Diet and lifestyle intervention

Diet and Exercise

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• yrs
• BMI ≥ 23 kg/m2

You may not qualify if:

• Type 1 or Type 2 Diabetes.
• On drugs or meal supplements for weight loss.
• On calcium and or vitamin D supplement currently or in the previous six months.
• Have past or current history or family history of renal stones.
• Have participated in any other investigational drug study in the previous three months.
• Have any systemic diseases (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in the last six months.
• Diagnosed malabsorption (celiac disease, Cohn's, ulcerative colitis) or history suggestive of malabsorption.
• Have past history of bariatric surgery

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Anoop misra

New Delhi, India

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: December 29, 2017
• Study Start: March 16, 2016
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: February 4, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)