The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
Completed · Phase 3
Conditions studied: Type 1 Diabetes
In brief
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
Key facts
- Study ID
- NCT00206297
- Run by
- Baylor College of Medicine
- People needed
- 20
- Starts
- 2003-10-01
- Expected to finish
- 2006-02-01
- 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…
- 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:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with diabetes for at least 2 years and in good control (HbA1C less than 8.5%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
- Hemoglobin equal to or > 12 g/dL before each study.
- Weight more than 44 kg. -
You may not qualify if…
- Age greater than 22 years or less than 12 years at the time of study
- 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
- Anemia (hemoglobin less than 12mg/dl)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
- Hgb A1C greater than or equal to 8.5 % in a diabetic subject
- BMI > 90 % tile for age or < 10 % tile for age
- Weight less than 44 kg. -
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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