Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

NCT00763412 | Completed Results DMC FDA Drug

• 2 other identifiers: 05-1109P60DK020579
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.

Conditions

Cystic Fibrosis Related Diabetes; Pancreatic Insufficiency

Keywords

Cystic Fibrosis; Diabetes; Cystic Fibrosis Related Diabetes; Pre-diabetes; oral hypoglycemic agents; Repaglinide; treatment; inflammatory markers; Lung function; nutrition

Outcome Measures

Primary Outcomes (3)

• BMI

  2 year/end of study

• Body Composition

  Reporting % of Fat and Lean body mass

  2 year/end of study

• CRP

  2 year/end of study

Secondary Outcomes (6)

• Glucose Tolerance

  2-year

• Inflammatory Markers

  2 year/end of study

• Wt Z Score

  2 year/end of study

• Tanner Stage

  2 year/end of study

• FEV 1

  2 year/end of study

Study Arms (2)

1 Placebo

PLACEBO COMPARATOR

1 pill before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance. Subjects were randomized to placebo or drug.

Drug: placebo

2. repaglinide

EXPERIMENTAL

repaglinide 0.5 mg before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance.Subjects were randomized to placebo or drug.

Drug: repaglinide

Interventions

placebo DRUG

CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.

1 Placebo

repaglinide DRUG

CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.

Also known as: Prandin

2. repaglinide

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or females 12 -24 years old
• Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
• Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose \<126 mg/dl and 2 hour: 140 - 199 mg/dl or \>200 mg/dl.
• Weight must be stable within 5% for 3 months prior to initiation visit
• Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines

You may not qualify if:

• Patients receiving growth hormone therapy or taking insulin
• Patients with evidence of liver dysfunction
• Patients who are status-post lung or liver transplantation
• Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
• Patients with active ABPA on steroids
• Patients taking medications that affect glucose metabolism or contraindicated with repaglinide

Sponsors & Collaborators

• Arbelaez, Ana Maria: lead
• Washington University School of Medicine: collaborator
• National Institutes of Health (NIH): collaborator
• Novo Nordisk A/S: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Diabetes Mellitus; Glucose Intolerance

Interventions

repaglinide

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Limitations and Caveats

A limitation of the study was the very small sample size.

Results Point of Contact

• Title: Ana Maria Arbelaez
• Organization: Washington University in St Louis

arbelaez_a@kids.wustl.edu

314-286-1138

Study Officials

• Neil H White, M.D.

  Washington University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatrics

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: October 1, 2008
• Study Start: November 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 5, 2017
• Results First Posted: June 5, 2017

Record last verified: 2017-05

Locations

US (1)