Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 13 - 20 |
| Updated: | 4/2/2016 |
| Start Date: | November 2012 |
| End Date: | December 2015 |
| Contact: | Larry A. Fox, MD |
| Email: | lfox@nemours.org |
| Phone: | 904-697-3674 |
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes
but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose
regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),
will be performed at baseline and again ~4 weeks after treatment with study drug. We will
also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before
each time the MMTT/OGTT are performed. Several hormones that may affect the way the body
regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will
assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine
has on the hormones measured during the OGTT and MMTT.
but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose
regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),
will be performed at baseline and again ~4 weeks after treatment with study drug. We will
also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before
each time the MMTT/OGTT are performed. Several hormones that may affect the way the body
regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will
assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine
has on the hormones measured during the OGTT and MMTT.
Inclusion Criteria:
- Patients with CF between 13 and <21 yrs old
- Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
- No history of CFRD
Exclusion Criteria:
- Insulin use in the last two months
- Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
- History of pancreatitis in the last 12 months
- Skin rashes or conditions that may affect CGM placement and wear
- Pregnancy or intent on becoming pregnant
- Patients on growth hormone therapy
- Renal insufficiency with creatinine clearance <50 ml/min (based on Schwartz formula)
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