Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

Nemours Children's Health

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Sitagliptin

Study type

Interventional

Funder types

Other

Identifiers

NCT01721382

CFRD-01

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

13 to 20 years old

Volunteers

No Healthy Volunteers

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)