Status:
COMPLETED
Determinants of Type 2 Diabetes Risk in Middle-aged Black South African Men and Women
Lead Sponsor:
University of Witwatersrand, South Africa
Collaborating Sponsors:
Medical Research Council, South Africa
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Insulin Resistance
Eligibility:
All Genders
35-65 years
Brief Summary
There is little known about menopause in African women, whose phenotype differs to Caucasian women, and no data is available on middle-aged black South African men. Accordingly, the study aims to exam...
Detailed Description
The study will be performed in two parts: Part 1 - Using a longitudinal design, a sample of 500 black women at different stages of the menopausal transition, and 500 middle-aged men living in Soweto ...
Eligibility Criteria
Inclusion
- Part 1:
- Women on whom baseline data was collected between 2011 and 2014 as part of the Study of Women Entering and in Endocrine Transition.
- Men on whom baseline data was collected in 2014 as part of a larger African genomics study (www.h3Africa.org).
- Part 2: A sub-sample of women from Part 1 of the study:
- Pre-menopausal women age-matched within the age range 35-45 years;
- Post-menopausal women age-matched within the age range 55-65 years;
- All women: BMI 25-40 kg/m2
Exclusion
- Part 1:
- \- Failed to consent to participate in the study.
- Part 2:
- Diabetes, thyroid dysfunction, inflammatory, hepatic and renal diseases;
- Use of hormone replacement therapy; hormonal contraceptives, oral cortisone, anti-inflammatory drugs or antiretroviral therapy;
- Peri-menopausal;
- Currently pregnant or lactating;
- Tobacco use.
Key Trial Info
Start Date :
January 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
1025 Patients enrolled
Trial Details
Trial ID
NCT03408678
Start Date
January 23 2017
End Date
July 31 2018
Last Update
June 14 2019
Active Locations (1)
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1
SAMRC/WITS Developmental Pathways of Health Research Unit, University of Witwatersrand
Johannesburg, Gauteng, South Africa, 2013