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Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721382
First Posted: November 5, 2012
Last Update Posted: June 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Drug: Sitagliptin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.

Resource links provided by NLM:


Further study details as provided by Larry Fox, Nemours Children's Clinic:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 6
Study Start Date: November 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Treatment with sitagliptin
Drug: Sitagliptin

  Eligibility

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721382


Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Larry A Fox, MD Nemours Children's Clinic
  More Information

Responsible Party: Larry Fox, Pediatric Endocrinologist, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01721382     History of Changes
Other Study ID Numbers: CFRD-01
First Submitted: October 26, 2012
First Posted: November 5, 2012
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Larry Fox, Nemours Children's Clinic:
cystic fibrosis
CF
CFRD
sitagliptin
incretins
GLP1
GIP
beta cell function
adolescents

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action