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Endothelial Function in Hispanic Children/Adolescents at Risk for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01926925
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Enrique Caballero, Joslin Diabetes Center

Brief Summary:

Type 2 diabetes is now more frequent in children/adolescents, especially in those from minority populations, including Hispanic Americans (HA). Diabetes and the pre-diabetes state markedly increase the risk of cardiovascular disease. Endothelial dysfunction is seen in the earliest stages of atherogenesis, which ultimately leads to cardiovascular disease. The main aim of this study is to evaluate the endothelial function in HA children/adolescents who are at risk for developing type 2 diabetes (obese children/adolescents from the Hispanic population).

The investigators' hypothesis is that endothelial dysfunction is present in this population and that it is associated with metabolic abnormalities linked to the insulin resistance syndrome. The investigators will study 2 groups of 15 individuals each, age 10-18 years. Group 1 will consist of obese (body mass index greater than 85th percentile for age and sex) Hispanic American children/adolescents and group 2 will consist of healthy, non-overweight (body mass index between the 25th and 50 th percentile for age and sex) Hispanic American children/adolescents.

The study will be carried out at the Joslin Diabetes Center. During the first day, participants will have a medical history and full physical examination, a standard OGTT and measurement of blood cell count, plasma glucose, insulin, lipids, HbA1c, BUN, creatinine, electrolytes, estradiol, testosterone, free fatty acids, CRP, endothelial markers, urinary microalbumin and hCG, if appropriate. An OGTT will be performed in order to rule out IGT or Diabetes. Estimations of insulin secretion and insulin sensitivity will be assessed using the homeostasis model assessment (HOMA). In the second day, the body composition and the brachial artery vasodilatory response to hyperemia will be assessed. Those found with diabetes will be tested for GAD-65 and IA2.

The investigators' hypothesis is that Hispanic American children/adolescents at risk for type 2 diabetes have impaired endothelial function and vascular reactivity that are associated with the degree of insulin resistance and its metabolic abnormalities.


Condition or disease
Obesity Insulin Resistance

Detailed Description:
Information as above

Study Type : Observational
Actual Enrollment : 38 participants
Time Perspective: Cross-Sectional
Official Title: Endothelial Function in Hispanic Children/Adolescents at Risk for Type 2 Diabetes
Study Start Date : May 2001
Actual Primary Completion Date : May 2010
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Overweight Hispanic children/adolescents
2
Lean Hispanic children/adolescents



Primary Outcome Measures :
  1. Plasma levels of markers of endothelial activation and vascular inflammation [ Time Frame: cross sectional study - one time evaluation ]

Biospecimen Retention:   Samples Without DNA
plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Hispanic children/adolescents
Criteria

Inclusion Criteria:

  • Group 1:

    1. Age between 10-18 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. No history of type 2 diabetes in any first-degree relative;
    4. Body mass index between the 25th and 50th percentile for age and sex
    5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Group 2:

  1. Age between 10-18 years;
  2. Hispanic (same criteria as above);
  3. Body mass index greater than the 85th percentile for age and sex;
  4. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Exclusion Criteria:

  • The exclusion criteria include: diabetes, 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, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926925


Sponsors and Collaborators
Joslin Diabetes Center
Investigators
Principal Investigator: Enrique Caballero, MD Joslin Diabetes Center

Responsible Party: Enrique Caballero, Clinical Investigator/Director Latino Diabetes Initiative, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01926925     History of Changes
Other Study ID Numbers: CHS#: 01-14
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Enrique Caballero, Joslin Diabetes Center:
Type 2 diabetes, Endothelium, children/adolescents

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism