New Onset Type 1 Diabetes: Role of Exenatide
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Exenatide; Rapid and long acting insulin; long acting insulin + rapid acting + 1.25 mcg Exenatide
Intervention description: 1.25 mcg before the boost sub-cutaneously.; Depends on their Carbohydrate ratio and body needs; Depends on their body needs.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Exenatide; Insulin Glargine; Insulin Detemir; Insulin, Long-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 1 diabetes Milletus; diabetes; healthy controls; exenatide; byetta

Summary:

      There are many recent advances in insulin treatment of type 1 diabetes, however after a meal
      sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to
      treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.
      This study is going to test whether this drug can improve the after meal sugars in people
      with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg)
      and long acting insulin or inulin alone before the boost. There is also a placebo group
      (healthy subjects) who do not get any medication before the boost. Insulin levels and other
      hormones that affect blood glucose as well as your sugar will be measured by a series of
      blood tests. The role exenatide as compared to insulin alone will be examined to prevent low
      blood sugars which might occur because of food staying longer in the stomach than usual or
      due to the suppression of a hormone called glucagon which increases blood sugar. If you
      qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone.
      You and the researchers will not know which dose you are taking at any single visit. A total
      of 20 people in which some will be children aged 12- 18 years will participate, being
      diagnosed within 3 months of having been found to have type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age between 12-18 years of age at the time of enrollment.

          2. Diagnosed with antibody positive T1DM in the past 3 months.

          3. Otherwise healthy except for their TIDM and treated hypothyroidism.

          4. Females must have a negative pregnancy test.

          5. Hemoglobin equal to or greater than 12 g/dl before each study.

          6. Weight greater than 44 kg.

        Exclusion Criteria:

          1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile
             rheumatoid arthritis etc, except for diabetes and hypothyroidism.

          2. Any medications that may affect glucose metabolism.

          3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).

          4. Lack of a supportive family environment as detected by the clinicians and/or social
             workers.

          5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire
             which will be administered at the screening visit).

          6. Positive pregnancy test in females.

          7. Lactating and nursing mothers.