New Onset Type 1 Diabetes: Role of Exenatide

Description

The specific aims of this study are to determine the following: 1. The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia. 2. The role of exenatide on postprandial glucagon and gastric emptying. 3. The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying. 4. Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls. Study Design: A randomized, non-blinded trial with a crossover design will be used. Following informed consent and with appropriate subject assent, all subjects will have a screening visit. Following the screening visit, subjects with T1DM will undergo 3 studies: Part A (exenatide and long acting insulin), Part B (rapid and long acting insulin) and Part C (long acting insulin only). The subjects will be admitted to the CRC on three separate occasions, at least 3-4 weeks apart. The three studies will be performed in a random order and the randomization will be done using a computerized system. The healthy controls will undergo a single study visit. Except for the absence of diabetes, the healthy controls will be identical to the study subjects. Subjects with new onset diabetes will be compared to healthy controls. During the study, if blood glucose values in a subject are less than 55 mg/dl, IV glucose of 5-15 grams will be administered to achieve euglycemia (90-130 mg/dl). 1-2 doses of IV glucose should correct hypoglycemia. If more than 3 doses are required to achieve euglycemia, the study will be terminated, the subject will be offered a meal tray and blood sugar rechecked to ensure euglycemia. If blood sugar at any time is more than 350 with moderate ketones, the study will be terminated. At around 1 PM (270 min), lunch will be provided (consistent carbohydrate meal) and insulin will be given as per the subject's prescribed regimen. The subject will be discharged home with a designated driver due to the risk of hypoglycemia. A subject will be withdrawn from participating in the study if he/she meets any of the following conditions: 1)develops a chronic disease 2)develops anemia 3)becomes pregnant 4)develops a weight loss of greater than 10 pounds for unspecified reasons 5)loss of contact- if the investigators are unable to reach a study subject (within 2 months of screening or completion of the first study) by phone or mail to schedule the next appointment. All study subjects (that are withdrawn from the study) will receive a phone call and a letter notifying them that they have been withdrawn.

Study Start Date

December 2010

Estimated Completion Date

December 2017

Interventions

  • Drug: Exenatide
  • Drug: Rapid and long acting insulin
  • Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide

Specialties

  • Internal Medicine: Clinical Pharmacology,Endocrinology
  • Endocrinology: Diabetes,Pharmacology/kinetics
  • Physician Assistant: Clinical Pharmacology,Endocrinology

MeSH Terms

  • Exenatide
  • Type 1 Diabetes

Study ID

Albert Einstein College of Medicine of Yeshiva University -- 2010 -435

Status

Unknown

Trial ID

NCT01269034

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

20

Sponsor

Albert Einstein College of Medicine of Yeshiva University

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.

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Albert Einstein CRC West Campus - Bronx, New York 40.3 miles None None None
Albert Einstein CRC West Campus - Bronx, New York 40.3 miles None None None

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