Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Determinants of Type 2 Diabetes Mellitus Risk in Middle-aged Black South African Men and Women: Dissecting the Role of Sex Hormones, Inflammation and Glucocorticoids
NCT number | NCT03408678 |
Other study ID # | M160604 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 23, 2017 |
Est. completion date | July 31, 2018 |
Verified date | June 2019 |
Source | University of Witwatersrand, South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 examine the changes in sex hormone levels over the menopausal transition in
women, and in men of the same age, and explore the effects on body fat distribution and
insulin sensitivity and secretion, dissecting the specific roles of glucocorticoids and
inflammatory mediators, in the context of HIV.
Research questions and hypotheses:
1. Does the decrease in sex hormones that occur with ageing increase circulating cortisol
and/or inflammatory markers, and directly and/or indirectly via increases in central fat
mass, decrease insulin sensitivity in middle-aged black South African men and women?
Hypothesis: The mechanism underlying the decrease in insulin sensitivity (outcome)
associated with the decline in sex hormones (exposure) that occurs with ageing is
mediated via an increase in centralization of body fat (mediator), which is due to an
increase in inflammation and cortisol production.
2. How does HIV alter the relationship between sex hormones, inflammation and cortisol
levels, and subsequently body fat distribution and insulin sensitivity?
Hypothesis: HIV infection will exacerbate the effects of the decline in sex hormones
with ageing, leading to further increases in inflammation and cortisol production, and a
consequent increase in the centralization of body fat and decrease in insulin
sensitivity.
3. Does adipose tissue glucocorticoid and inflammatory gene expression differ between pre-
and post-menopausal women, with and without HIV, and how do these relate to body fat
distribution and insulin sensitivity and secretion?
Hypothesis: Adipose tissue estrogen receptor beta (ERβ), 11-beta hydroxysteroid dehydrogenase
type 1 (11HSD1) activity and pro-inflammatory markers will be higher in post- compared to
pre-menopausal women, which will be exacerbated by HIV infection. This will be associated
with down-regulation of subcutaneous adipose tissue (SAT) adipogenic genes, increased
visceral adipose tissue (VAT), a decrease in insulin sensitivity and secretion, and
consequently an increased risk for type 2 diabetes (T2D).
Status | Completed |
Enrollment | 1025 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | SAMRC/WITS Developmental Pathways of Health Research Unit, University of Witwatersrand | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Witwatersrand, South Africa | GlaxoSmithKline, Medical Research Council, South Africa, University Hospital, Umeå, University of Oxford |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin sensitivity and secretion | Part 1: insulin sensitivity and secretion estimated from an oral glucose tolerance test; Part 2: insulin sensitivity and secretion estimated using a frequently sampled intravenous glucose tolerance test | 4-6 years | |
Secondary | Body fat distribution | Body fat depots measured using dual energy x-ray absorptiometry | 4-6 years |
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