Adiponectin and Ethnic Differences in Insulin Resistance | NCT01831102

Studies
Adiponectin and Ethnic Differences in Insulin Resistance

NCT01831102

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Apr 15, 2013Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Insulin Resistance
Type 2 Diabetes

Interventions

none- observational study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Apr 5, 2013

First Submission Date that Met QC Criteria

Apr 9, 2013

First Posted Date

Apr 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2013

Last Update Posted Date

Apr 15, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-Latino white		no Latino ancestry, Caucasian	Other: none- observational study
Mexican American		Mexican American ancestry	Other: none- observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
none- observational study	Other		Mexican American non-Latino white

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total adiponectin concentration		measured once during second study visit, in fasting condition

Secondary Outcomes

Measure	Description	Time Frame
Insulin sensitivity	Calculated from insulin and glucose values obtained during IV glucose tolerance test.	Measured once, during second study visit.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-60 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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rocio Pereira, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Center		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided