NCT02105909

Brief Summary

This is a GWAS pilot study that aims to identified possible candidate genes associate to obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese , metabolically healthy white adults, matched with lean, white adults , metabolically healthy. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with obesity (as defined by BMI).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

4.5 years

First QC Date

March 26, 2014

Last Update Submit

April 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of SNPs associated with high BMI

    Using GWAS to identify candidate genes associate with obesity (high BMI) in a carefully phenotyped white adults with obesity (as defined by BMI), metabolically healthy, matched with lean, white adults metabolically healthy.

    baseline

Study Arms (2)

obese subjects

EXPERIMENTAL

DNA analysis

Other: GWAS

lean subjects

PLACEBO COMPARATOR

DNA analysis

Other: GWAS

Interventions

GWASOTHER
lean subjectsobese subjects

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults 40 year old or older
  • Caucasian males or females
  • BMI ≥ 35 kg/m² or history of BMI ≥ 35 kg/m², or BMi less than 25 kg/m2
  • No current or past use of glucose lowering drugs
  • No current or past medical history of diabetes mellitus
  • No current or past medical history of established coronary artery disease (angina, myocardial infraction, abnormal cardiac stress test)
  • No current or past medical history of or treatment for thyroid disorders
  • No current or past use of lipid lowering drugs or diagnosis of a lipid disorder
  • No current or past medical history of or treatment for hypertension
  • Subject's willingness to provide the study investigators with a copy of their medical records or give permission to the study investigators to access the following specific medical information:
  • Fasting plasma glucose (less than 100 mg/dL/5.6 mmol/L)
  • HDL-C cholesterol (more than 40 mg/dL /1.03 mmol/L)
  • Total cholesterol (less than 239 mg/dL/ 6.18mmol/L)
  • LDL cholesterol (less than 159 mg/dL/4.11 mmol/L)

You may not qualify if:

  • \- Known monogenic forms of obesity
  • Polycystic ovary disease (in women)
  • Malabsorptive or maldigestive syndromes (Celiac disease, Crohn's Disease, inflammatory bowel disease, etc.)
  • Anorexia nervosa or bulimia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 7, 2014

Study Start

May 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 7, 2014

Record last verified: 2014-04