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Insulin Resistance and Insulin Secretion

Primary Purpose

Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diet
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Ascertainment criteria for probands: age 10-20 years and obesity (BMI >85% for sex and age) diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes

Sites / Locations

  • Columbia Presbyterian Medical Center/ Irving Center
  • Russ Berrie Pavilion

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 18, 2003
Last Updated
February 28, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00073294
Brief Title
Insulin Resistance and Insulin Secretion
Official Title
Phenotypic Assessment of Insulin Resistance and Insulin Secretory Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Trial was not funded
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. We hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. By isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ascertainment criteria for probands: age 10-20 years and obesity (BMI >85% for sex and age) diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes
Facility Information:
Facility Name
Columbia Presbyterian Medical Center/ Irving Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Russ Berrie Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Insulin Resistance and Insulin Secretion

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