The Role of Amylin and Glucagon in T1DM

Completed · Phase 3

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00206258

Run by

Baylor College of Medicine

People needed

30

Starts

2002-07-01

Expected to finish

2005-08-01

Last updated by the study team

2016-07-14

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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