The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours

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

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:

1. Between 12-21 years of age at the time of enrollment.

2. Have been diagnosed with diabetes for at least 2 years and in good control (HbA1C less than 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 > 12 g/dL before each study.

7. Weight more than 44 kg. -

Exclusion Criteria:

1. Age greater than 22 years or less than 12 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 or equal to 8.5 % in a diabetic subject

8. BMI > 90 % tile for age or < 10 % tile for age

9. Weight less than 44 kg. -