Type 1 Diabetes Clinical Trial
Official title:
Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study
Verified date | July 2016 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to see if giving the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.
Status | Completed |
Enrollment | 13 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 22 Years |
Eligibility |
Inclusion Criteria: These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be 1. 13-22 years of age at the time of enrollment. 2. Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%). 3. Be on continuous subcutaneous insulin infusion using an insulin pump. 4. Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism. 5. Menstruating women must have a negative pregnancy test. 6. Hemoglobin equal to or greater than 12 g/dL before each study. 7. Weight more than 44 kg. - Exclusion Criteria: 1. Age greater than 23 years or less than 13 years at the time of study 2. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications 3. Anemia (hemoglobin less than 12mg/dl) 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 greater than 8.5 % in a diabetic subject 8. BMI > 90 % tile for age or < 10 % tile for age 9. Weight less than 44 kg. - |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | 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 | 4 hrs | No | |
Secondary | glucagon and gastric emptying | 4 hrs | No |
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