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Exposure to Type II Diabetes for Two Siblings With the Same Parents (T2DM)

This study is currently recruiting participants.
Verified December 2012 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Darcy Johannsen, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01275235
First received: January 10, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at greater risk for the disease, and studies have shown that how the body responds to insulin, how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often different in these individuals at a young age compared to people without a family history of the disease. The tendency to develop T2DM is influenced strongly by genetics; however, exposure to the surrounding environment may also play a role. The exposure to a diabetic environment while in the womb represents an altered nutritional exposure (high levels of circulating sugar, or glucose) that may affect how tissues important in regulating energy metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Metabolic Traits of Adult Sib-pairs Discordant for Intrauterine Diabetes Exposure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Risk of type 2 diabetes mellitus (T2DM) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The purpose is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did not have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).


Biospecimen Retention:   Samples Without DNA

Whole blood, urine and muscle cell.


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposure to Type II Diabetes for two siblings
Two sibling pairs with the same parents, between the ages of 20 to 34 in the Baton Rouge Area, having mother with diabetes while pregnant with one.

Detailed Description:

A one-time testing comprising of 2 days (32 consecutive hours). A medical history and physical including questions about medications, health status and symptoms are acquired at the fasting screening visit. Both siblings must meet all study eligibility requirements to be enrolled into the study. If enrolled for the 2 days, you will be in a metabolic chamber, dual energy x-ray absorptiometry (DXA) scan, biopsy, oral glucose tolerance test, and magnetic resonance imaging (MRI).

  • Metabolic chamber is a room is a sophisticated system that allows your oxygen / carbon dioxide exchange to be measured, thereby showing the number of calories you are burning.
  • DXA is a scan that measure the amount of bone, muscle, and fat in your body.
  • Biopsy is a procedure to sample muscle cells from underneath the skin.
  • OGTT is Oral Glucose Tolerance Test from an IV line for blood samples once you drink a sugar solution consisting of glucose.
  • MRI scan is to measure the amount of fat in your abdomen around the organs and underneath the skin.
  Eligibility

Ages Eligible for Study:   20 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community

Criteria

Inclusion Criteria:

  • You are one of a sibling pair with the same mother and father, and your mother had diabetes (gestational or type 2) while she was pregnant with the younger sibling but not the older sibling.
  • Your sibling is willing to participate in the study.
  • You are between the ages of 20 and 34 years (inclusive)
  • Your body mass index is between 20 and 29 Kg/m2 inclusive (this is a number calculated for your height and weight and indicates that you are either normal weight or overweight, but not obese).
  • You are healthy as assessed by medical history and standard physical examination
  • You are weight stable (your body weight has not changed .6.5 lbs over the last 3 months).
  • You do not smoke
  • You provide written informed consent to participate in the study.
  • You are willing to stay overnight one time at the Pennington Center.
  • You have low physical activity (< 100 min of exercise per week).

Exclusion Criteria:

  • You were born prematurely (<37 weeks of pregnancy)
  • You are currently taking medication that may influence your body weight or metabolism.
  • You have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275235

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Dawn Rachal     225-763-2733     Dawn.Rachal@pbrc.edu    
Contact: Grace Bella     225-276-3000     doctors@pbrc.edu    
Principal Investigator: Darcy Johannsen, PhD, RD            
Principal Investigator: Eric Ravussin, PhD            
Principal Investigator: Frank Greenway, MD            
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

Publications:

Responsible Party: Darcy Johannsen, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01275235     History of Changes
Other Study ID Numbers: PBRC10016
Study First Received: January 10, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013