Status:
COMPLETED
Randomized Control Trial for Overweight Employees in Worksites
Lead Sponsor:
Diabetes Foundation, India
Collaborating Sponsors:
Sprim Advanced Life Sciences
Abbott
Conditions:
Diabetes Mellitus, Type 2
Metabolic Syndrome
Eligibility:
All Genders
25-55 years
Phase:
NA
Brief Summary
Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely unexplored. The aim of this study was to assess impact of the multi-component interventions on body weight, body f...
Detailed Description
A randomized open label clinical trial is planned in 4 worksites. The total study duration is 18 months. Four workplace sites will be divided into two active intervention and two control sites. Intens...
Eligibility Criteria
Inclusion
- Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
- Individuals who are willing to participate in the study
Exclusion
- Previously diagnosed diabetics and patients with coronary artery disease.
- Have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors
- Pregnant and lactating women
- Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc.
- Known case of HIV infection
- Unwillingness to participate in the study
Key Trial Info
Start Date :
March 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03249610
Start Date
March 11 2014
End Date
June 15 2017
Last Update
August 15 2017
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