NCT01831102

Brief Summary

The purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

April 5, 2013

Last Update Submit

April 9, 2013

Conditions

Insulin ResistanceType 2 Diabetes

Keywords

insulin resistanceethnic disparitiesadiponectin

Outcome Measures

Primary Outcomes (1)

  • total adiponectin concentration

    measured once during second study visit, in fasting condition

Secondary Outcomes (1)

  • Insulin sensitivity

    Measured once, during second study visit.

Study Arms (2)

non-Latino white

no Latino ancestry, Caucasian

Other: none- observational study

Mexican American

Mexican American ancestry

Other: none- observational study

Interventions

none- observational studyOTHER
Mexican Americannon-Latino white

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • years of age
  • BMI 20.0-34.9 m/kg2
  • Mexican American with at least 3 grandparents born in Mexico or white with no grandparents of Latino descent.

You may not qualify if:

  • pregnancy
  • breastfeeding
  • diabetes mellitus
  • blood pressure \> 160/100 mmHg
  • creatinine \> 1.5 mg/dl or glomerular filtration rate (GFR) \< 60
  • liver function tests \> 3x upper limit of normal (ULN)
  • h/o heart failure
  • h/o eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Rocio Pereira, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 15, 2013

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

US(1)