Clinical Trial: Diet/Growth Factor Mechanisms of Gut Adaptation


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Diet/Growth Factor Mechanisms of Gut Adaptation

This study is currently recruiting patients.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Condition	Treatment or Intervention	Phase
Short Bowel Syndrome	Drug: recombinant human growth hormone Behavior: diet modification	Phase II

MedlinePlus related topics: Digestive Diseases

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

Further Study Details:

Expected Total Enrollment: 30

Study start: October 1996

Eligibility

Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both

Criteria

Parenteral nutrition-dependent adults with short gut syndrome.
Patients must not have diabetes mellitus or active malignancy within the past 5 years.

Location and Contact Information

Georgia
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting

Thomas R Ziegler, MD 404-727-7351 tzieg01@emory.edu
Li H Gu, MD 404-727-5806 lgu@emory.edu

More Information

Study ID Numbers: DGFMGA
Record last reviewed: August 2004
Record first received: August 29, 2003
ClinicalTrials.gov Identifier: NCT00067860
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08

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