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

NCT01275235 | Terminated

• 1 other identifier: PBRC 10016
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Risk of type 2 diabetes mellitus (T2DM)

  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).

  2 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• Warram JH, Martin BC, Krolewski AS, Soeldner JS, Kahn CR. Slow glucose removal rate and hyperinsulinemia precede the development of type II diabetes in the offspring of diabetic parents. Ann Intern Med. 1990 Dec 15;113(12):909-15. doi: 10.7326/0003-4819-113-12-909.

  PMID: 2240915 BACKGROUND

• Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

  PMID: 24500151 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, urine and muscle cell.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Darcy Johannsen, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

US (1)