View Clinical Trial (Medical Research Study)
New Onset Type 1 Diabetes: Role of Exenatide
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10467 |
| Conditions: |
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Type 1 Diabetes - New Onset Type 1 Diabetes |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01269034 |
| Primary Contact: |
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Principal Investigator
Rubina A Heptulla, MD
Albert Einstein College of Medicine of Yeshiva University
Jeniece Trast, RN,CDE
Phone: 718-920-6191
Email: jtrast@montefiore.org
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| Backup Contact: |
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Email: vrenukun@montefiore.org
Venkat Renukuntla, MBBS, MPH
Phone: 718-920-7004
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| Location Contact: |
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Bronx, New York 10467
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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