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Diet/Growth Factor Mechanisms of Gut Adaptation

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00067860
First received: August 29, 2003
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  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 Intervention Phase
Short Bowel Syndrome
 Drug: recombinant human growth hormone
Behavioral: diet modification
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Diet/Growth Factor Mechanisms of Gut Adaptation

Further study details as provided by Emory University:

Estimated Enrollment: 30
Study Start Date: October 1996
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Parenteral nutrition-dependent adults with short gut syndrome.
  • Patients must not have diabetes mellitus or active malignancy within the past 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067860

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Thomas R Ziegler, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00067860     History of Changes
Other Study ID Numbers: DK55850, R01DK055850, DK55850
Study First Received: August 29, 2003
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
 Mitogens
Hormones
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013