NCT01926938

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2003

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

9.7 years

First QC Date

August 19, 2013

Last Update Submit

August 20, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • markers of endothelial activation, coagulation and inflammation

    cross sectional evaluation

Study Arms (2)

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 Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Enrique Caballero, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator/Director, Latino Diabetes Initiative

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

May 1, 2003

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations