Obesity Clinical Trial
Official title:
Vitamin D Receptor and Megalin Gene Polymorphisms and Their Association With Obesity, Central Obesity and the Metabolic Syndrome
Verified date | September 2017 |
Source | National Institute on Aging (NIA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The link between metabolic disturbances and vitamin D receptor (VDR) and MEGALIN (or LRP2)
gene polymorphisms remains unclear, particularly among African-American adults. The
associations of single nucleotide polymorphisms (SNPs) for VDR [rs1544410(BsmI:G/A),
rs7975232(ApaI:A/C), rs731236(TaqI:G/A)] and MEGALIN [rs3755166:G/A,rs2075252:C/T,
rs2228171:C/T] genes with incident and prevalent metabolic disturbances, including obesity,
central obesity and metabolic syndrome (MetS) were evaluated.
From 1,024 African-Americans participating in the Healthy Aging in Neighborhoods of Diversity
across the Life Span (HANDLS, Baltimore, MD, 2004-2013) study, 539 subjects were selected who
had complete genetic data as well as covariates selected for metabolic outcomes at two
consecutive examinations (visits 1 and 2) with a mean follow-up time of 4.64±0.93y. Haplotype
(HAP) analyses generated polymorphism groups that were linked to incident and prevalent
metabolic disturbances.
Status | Completed |
Enrollment | 1021 |
Est. completion date | July 7, 2013 |
Est. primary completion date | July 7, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. 3,720 baseline participants (mean±SD age(y) of 48.3±9.4, 45.3% men, and 59.1% African-American), 2. Genetic data were available on 1,024 African-American participants. 3. Incomplete covariate data reduced the sample to n=769, while additional exclusions lead to a sample size ranging between 574 and 598 participants, with 539 having complete data on all baseline and follow-up outcome measures (cross-sectional part of the analysis). 4. In the longitudinal analysis, metabolic disturbance-free at baseline participants were selected for each outcome. Sample sizes ranged from n=246 (central obesity-free) to n=466 (hyperglycemia-free). 5. There were n=294 MetS-free individuals at baseline. Exclusion Criteria: 1. Whites in HANDLS, since they did not have any genetic data collected. 2. All African-Americans in HANDLS without genetic data collected. 3. All African-Americans in HANDLS with genetic data collected, who had incomplete data on key outcome variables and/or basic covariates of interest. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Institute on Aging (NIA) |
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Obesity | Obesity was defined as BMI=30 kg/m2. | 2004-2013 | |
Primary | Central Obesity | Central obesity was defined based on waist circumference (WC) = 102 cm or 40 inches (men), = 88 cm or 35 inches (women) | 2004-2013 | |
Primary | Metabolic Syndrome | Participants who screened positive on at least 3 of 5 conditions ((1) central obesity (see above); (2) dyslipidemia: TAG=1.695 mmol/L (150 mg/dl); (3) dyslipidemia: HDL-C<40 mg/dL (male), <50 mg/dL (female); (4) blood pressure=130/85 mmHg; (5) fasting plasma glucose=6.1 mmol/L (110 mg/dl).(39)) were classified as MetS-positive (2) Similarly, continuous annual rates of change (?) in metabolic outcomes were considered, specifically number of metabolic disturbances (MetD), BMI, WC, SBP, DBP, TAG, HDL-C, and Glucose. Binary incident outcomes included obesity, central obesity, MetS and other metabolic disturbance (i.e. hypertension, dyslipidemia-TAG, dyslipidemia-HDL and hyperglycemia). | 2004-2013 |
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