The Role of Amylin and Glucagon in T1DM

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Glucagon; Glucagon-Like Peptide 1; Pramlintide

Criteria

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