Status:
COMPLETED
The Role of Amylin and Glucagon in T1DM
Lead Sponsor:
Baylor College of Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-21 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Objective: To develop a new treatment approach in the prevention of hypo and hyperglycemia in children with type 1diabetes. Background/Rationale: The diabetes control and complications trial (DCCT) s...
Eligibility Criteria
Inclusion
- Age \>12 years \< 19 years
- Have diabetes for at least 2 years and in good control (HbA1C \< 8%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.
- Menstruating women must have negative pregnancy test.
- Hemoglobin equal to or \> than 12 g/dL before each study.
- Weight more than 44 kg.
Exclusion
- Age \>18 or \< 12 y at the time of study
- 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
- 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)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
- Hgb A1c \>8.0 % in a diabetic subject
- BMI \> 90 % tile for age or \< 10 % tile for age
- Allergy to local anesthetics (ELAMAX Cream)
- Weight less than 44 kg
- Children of staff members
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00206258
Start Date
July 1 2002
End Date
August 1 2005
Last Update
July 14 2016
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030