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Diet/Growth Factor Mechanisms of Gut Adaptation

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ClinicalTrials.gov Identifier: NCT00067860
Recruitment Status : Completed
First Posted : September 1, 2003
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: recombinant human growth hormone Behavioral: diet modification Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Diet/Growth Factor Mechanisms of Gut Adaptation
Study Start Date : October 1996
Primary Completion Date : December 2006
Study Completion Date : December 2006

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Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas R. Ziegler, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00067860     History of Changes
Other Study ID Numbers: IRB00035030
R01DK055850 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2003    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

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