Clinical Trial: Diabetes Therapy to Improve BMI and Lung Function in CF


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Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cystic Fibrosis Foundation Novo Nordisk Pharmaceuticals
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

Condition	Treatment or Intervention	Phase
Cystic Fibrosis Diabetes Mellitus	Drug: Insulin Aspart Drug: Rapaglinide	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both

Accepts Healthy Volunteers

Diabetic glucose pattern by oral glucose tolerance test (OGTT) of >200 at 120 min. (stable and healthy at time of OGTT)
Fasting glucose levels <126.
Weight stable within 5% in previous 3 months.
Free from illness for two months.
Male and female 16 and older, who are done growing
Willing to come in for visits every 3 months.
Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months

Trish Grover, RN 612-624-0135 grove026@umn.edu

California
Stanford University, Palo Alto, California, 94304, United States; Recruiting

Noreen Henig, MD 650-723-6381 nhenig@leland.stanford.edu
Julia Matel, MS, RD 650-736-2128 JMatel@stanfordmed.org
Noreen Henig, MD, Sub-Investigator

Massachusetts
Baystate Medical Center, Springfield, Massachusetts, 01199, United States; Recruiting

Holley Allen, MD 413-794-4441 holley.allen@bhs.org
Holley Allen, MD, Sub-Investigator

Minnesota
University of Minnesota Medical Center, Minneapolis, Minnesota, 55455, United States; Recruiting

Trish Grover, RN 612-624-0135 grove026@umn.edu
Antoinette Moran, M.D., Principal Investigator

Pennsylvania
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213-2583, United States; Recruiting

Joseph Pilewski, MD 412-692-2164 pilewskijm@msx.upmc.edu
Elizabeth Hartigan, RN, MPH 412-692-5630 elizabeth.hartigan@chp.edu
Joseph Pilewski, MD, Sub-Investigator

Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232-2650, United States; Recruiting

Bonnie Slovis, MD 615-322-3412 bonnie.solvis@vanderbilt.edu
Susan France, MS, FNP 615-322-3048 susan.france@vanderbilt.edu
Bonnie Solvis, MD, Sub-Investigator

Utah
University of Utah, Salt Lake City, Utah, 84132-4701, United States; Recruiting

Theodore Liou, MD 801-581-7806 ted.liou@hsc.utah.edu
Judy Jensen, MS 801-581-3961 judy.jensen@hsc.utah.edu
Ted Liou, MD, Sub-Investigator

Canada, Ontario
St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada; Recruiting

Elizabeth Tullis, MD 416-864-5651 tullise@smh.toronto.on.ca
Lesley Gaskin, RN 416-864-5651 gaskinl@smh.toronto.on.ca
Elizabeth Tullis, MD, Sub-Investigator