Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00287456
First received: February 2, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased HGP.


Condition Intervention
Cystic Fibrosis Related Diabetes
Device: Insulin Pump
Drug: Insulin
Procedure: Oral Glucose Tolerance Test
Procedure: Whole body Protein Turnover

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • - weight gain
  • - gain of lean body mass
  • - increased protein synthesis
  • - decreased protein breakdown.

Estimated Enrollment: 16
Detailed Description:

The insulin pump provides standard treatment for many patients with type 1 and type 2 diabetes and has been proven to be more effective in blood glucose control than subcutaneous injections. However, the pump has not been utilized for CF related diabetes. The insulin pump is connected to the patient via a small plastic catheter. The catheter is inserted with a 24 gauge needle (in a fashion similar to an IV catheter) just under the skin. The catheter is then changed every three days. The patient wearing the pump may then give himself or herself a “bolus dose” of insulin every time he or she eats, without needing to give a shot. A further advantage of the pump is that a very low dose of basal insulin may be given throughout the day. This low dose of insulin mimics the normal pancreas and may be especially advantageous for the insulin deficient CF patient. It is likely that bolus dosing will improve high HGP and will be more effective than subcutaneous insulin. Furthermore, continuous basal insulin will likely improve protein catabolism.

This is a pilot study to determine efficacy of the insulin pump. Each subject will be provided with the pump and with all materials needed for use with the pump. Each patient will also be provided with a glucose meter and test strips. He/she will be asked to wear the pump for six months and to check his/her blood sugar levels three to four times per day. Prior to the pump placement and at the end of six months, each patient will undergo the following measurements: 1) whole body protein turnover using the stable isotope [1-13C] leucine; 2) DEXA scan for measurement of lean body mass; 3) anthropometric measurements; 4) Hemoglobin A1c.

  Eligibility

Ages Eligible for Study:   12 Years to 32 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cystic fibrosis patients aged 12-32 years
  • Impaired glucose tolerance or CFRD defined as fasting blood glucose (FBG) and post-prandial blood glucose (pp) equal to: FBG <126 and pp 151-200, or FBG <126 and pp >200, or FBG >126 and pp >200.
  • Type 1 diabetes control patients aged 12-32 years.

Exclusion Criteria:

  • Colonization with Burkholderia cepacia
  • currently on corticosteroid medication
  • pregnant
  • medically unstable
  • Unable to understand the insulin pump directions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287456

Locations
United States, Texas
Children’s Medical Center of Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00287456     History of Changes
Other Study ID Numbers: 0901-466
Study First Received: February 2, 2006
Last Updated: February 2, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Diabetes Mellitus
Fibrosis
Glucose Intolerance
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperglycemia
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014