Clinical Trials Directory

Trials / Terminated

TerminatedNCT01275235

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

Metabolic Traits of Adult Sib-pairs Discordant for Intrauterine Diabetes Exposure.

Status
Terminated
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
All
Age
20 Years – 34 Years
Healthy volunteers
Accepted

Summary

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).

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.

Conditions

Timeline

Start date
2012-12-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2011-01-12
Last updated
2016-04-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01275235. Inclusion in this directory is not an endorsement.