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

Sponsor

Joslin Diabetes Center (Other)

Overall Status

Completed

CT.gov ID

NCT01926938

Collaborator

(none)

Enrollment

Location

116.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Time Perspective:

Cross-Sectional

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

markers of endothelial activation, coagulation and inflammation [cross sectional evaluation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Group 1:

Age between 18-40 years;
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?");
History of type 2 diabetes in one or both parents;
BMI above 27;
Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Group 2:

Age between 18-40 years;
Hispanic (same criteria as above );
No history of type 2 diabetes in any first degree relative;
BMI under 25;
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

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Joslin Diabetes Center

Investigators

Principal Investigator: Enrique Caballero, MD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enrique Caballero, Clinical Investigator/Director, Latino Diabetes Initiative, Joslin Diabetes Center

ClinicalTrials.gov Identifier:

NCT01926938

Other Study ID Numbers:

CHS#: 03-30

First Posted:

Aug 21, 2013

Last Update Posted:

Aug 21, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Aug 21, 2013