Type 1 Diabetes Clinical Trial
Official title:
The Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes
Verified date | July 2016 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years to 21 Years |
Eligibility |
Inclusion Criteria: 1. Age >12 years < 19 years 2. Have diabetes for at least 2 years and in good control (HbA1C < 8%). 3. Be on continuous subcutaneous insulin infusion using an insulin pump. 4. Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism. 5. Menstruating women must have negative pregnancy test. 6. Hemoglobin equal to or > than 12 g/dL before each study. 7. Weight more than 44 kg. Exclusion Criteria: 1. Age >18 or < 12 y at the time of study 2. Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis 3. Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies) 4. Lack of a supportive family environment 5. Positive pregnancy test in menstruating young women 6. Evidence or history of chemical abuse 7. Hgb A1c >8.0 % in a diabetic subject 8. BMI > 90 % tile for age or < 10 % tile for age 9. Allergy to local anesthetics (ELAMAX Cream) 10. Weight less than 44 kg 11. Children of staff members |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve for glucose | |||
Secondary | Glucagon and gastric emptying |
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