Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-28 @ 6:32 AM
Study NCT ID:
NCT01275235
Status:
TERMINATED
Last Update Posted:
2016-04-05
First Post:
2011-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exposure to Type II Diabetes for Two Siblings With the Same Parents
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Metabolic Traits of Adult Sib-pairs Discordant for Intrauterine Diabetes Exposure.
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were unable to recruit enough sibling pairs in a timely manner.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T2DM
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: