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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enrique Caballero, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01926938
First received: August 19, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition
Obesity
Insulin Resistance

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • markers of endothelial activation, coagulation and inflammation [ Time Frame: cross sectional evaluation ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: May 2003
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01926938

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
Principal Investigator: Enrique Caballero, MD Joslin Diabetes Center
  More Information

No publications provided

Responsible Party: Enrique Caballero, Clinical Investigator/Director, Latino Diabetes Initiative, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01926938     History of Changes
Other Study ID Numbers: CHS#: 03-30
Study First Received: August 19, 2013
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014