Diet/Growth Factor Mechanisms of Gut Adaptation | NCT00067860

Studies
Diet/Growth Factor Mechanisms of Gut Adaptation

NCT00067860

Sponsor

Emory University

Status

Completed

Last Update Posted

May 16, 2016Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Short Bowel Syndrome

Interventions

recombinant human growth hormone
diet modification

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK055850	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 1996

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Aug 29, 2003

First Submission Date that Met QC Criteria

Aug 29, 2003

First Posted Date

Sep 1, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2016

Last Update Posted Date

May 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas R. Ziegler, MD, Professor of Medicine, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas R Ziegler, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University School of Medicine		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D012778	Short Bowel Syndrome

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone
D004035	Diet Therapy

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
recombinant human growth hormone	Drug
diet modification	Behavioral