The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM).

Completed

Conditions studied: Type 2 Diabetes

In brief

To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal challenge. Specifically we will be measuring the following parameters of postprandial metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3. Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate

Key facts

Study ID

NCT00361946

Run by

Baylor College of Medicine

People needed

45

Starts

2006-08-01

Expected to finish

2010-07-01

Last updated by the study team

2017-04-24

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group A- Lean Adolescents a. Inclusion criteria: This group will consist of 20 lean adolescents between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, have a BMI less than 85th and above 20th for age and an HbA1C less than or equal to 6% (normal range is 4-6%). They should not be taking any medications. A DXA scan will be performed to estimate lean and fat body mass. The body fat mass should be less than or equal to 25 % to be included in this group (in the lean range). The subjects will be matched for age and Tanner stage to the subjects in Group B and C. Menstruating females must have a negative urine pregnancy test for inclusion.The subject must weigh more than 43 kg.
• Group B- Obese Adolescents a. Inclusion criteria: This group will consist of obese adolescents, between the ages of 12-18 years and Tanner stage 3-5 for pubertal development. They must have: a BMI above or equal to 95th for age, but not greater than 40 kg/m2 . They must have a normal glucose tolerance, in other words subjects with undiagnosed impaired glucose tolerance or diabetes will not be considered for the study. To test them for diabetes or impaired glucose tolerance they will undergo a 2-hour Glucose tolerance test (2hr-GTT). The ADA criteria will be used for the diagnosis of diabetes and/or impaired glucose tolerance (fasting plasma glucose < 110 mg/dl and a 2 hour postprandial blood glucose < 140 mg/dl). They must have and normal liver function tests and not taking any medications. The subjects will undergo DXA scan for estimation of total lean and fat body mass. The fat mass should be more than or equal to 30% to be considered obese. The subjects in this group will be matched for age (plus minus 1year), Tanner stage (plus minus 1) and body fat mass (plus minus 5%) to the Type 2 diabetes adolescents?. Menstruating females must have a negative urine pregnancy test for inclusion. 3. Group C- T2DM Adolescents a. Inclusion criteria The study group will consist of adolescents with T2DM, between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, BMI above or equal to 85th for age (but less than 40 kg/m2) and HbA1c less than 8.5%. They must have T2DM diagnosed for at least 2years, treated with diet , oral hypoglycemic agents and or insulin. If on medications they need to be on a stable dose of insulin and / or oral hypoglycemic agent over the last 2 months. The subjects must be otherwise healthy except for hypothyroidism stable on treatment. Menstruating females must have a negative urine pregnancy test for inclusion. -

You may not qualify if…

• Group A- Lean Adolescents a. Exclusion criteria: The subjects will be excluded if they have: a history of chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc), allergy to local anesthetics (ELAMAX Cream), evidence or history of chemical abuse, anemia and elevated liver enzymes (AST above 80 U/L and ALT above 110 U/L).
• Group B- Obese Adolescents a. Exclusion criteria: The exclusion criteria are the same as for control group A.
• Study Group C- T2DM Adolescents a. Exclusion Criteria: The exclusion criteria will be the same as in the control groups with one addition, subjects may not have been admitted to the hospital for diabetic ketoacidosis in the last 6 months.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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