Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes

August 20, 2013 updated by: Enrique Caballero, Joslin Diabetes Center
Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Young Latino adults with and without family history of type 2 diabetes

Description

Inclusion Criteria:

  • Group 1:

    1. Age between 18-40 years;
    2. Hispanic (we will consider a subject being Hispanic if both parents are reported as Hispanics when asked the following question: "What ethnic group do you consider that you belong to?");
    3. History of type 2 diabetes in one or both parents;
    4. BMI above 27;
    5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Group 2:

  1. Age between 18-40 years;
  2. Hispanic (same criteria as above );
  3. No history of type 2 diabetes in any first degree relative;
  4. BMI under 25;
  5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Exclusion Criteria:

  • diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
adults at risk
Latino adults with family history of type 2 diabetes
controls
Latino adults without family history of type 2 diabetes and normal glucose tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
markers of endothelial activation, coagulation and inflammation
Time Frame: cross sectional evaluation
cross sectional evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CHS#: 03-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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