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Completed

NCT Number: NCT01721382

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sitagliptin

Drug

Primary outcomes

  1. Response to sitagliptin

    Time frame: Change from baseline to ~4 weeks of study drug

    Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.

  2. Response to sitagliptin

    Time frame: Change from baseline to ~4 weeks of study drug

    Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.

  3. Response to sitagliptin

    Time frame: Change from baseline to ~4 weeks of study drug

    Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.

  4. Response to sitagliptin

    Time frame: Change from baseline to ~4 weeks of study drug

    Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.

Secondary outcomes

  1. Beta-cell function

    Time frame: Change from baseline to ~4 weeks of study drug

    Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT.

  2. Continuous glucose monitoring (CGM)

    Time frame: change from baseline to ~4 weeks of study drug

    Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2012
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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