Comparison of Enteral Products for Tube Fed Patients With... | NCT00544206

Studies
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

NCT00544206

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Sep 23, 2008Estimated

Enrollment

11Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

standard enteral feeding product
Diabetes specific feeding product

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

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 16, 2007Estimated

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

Sep 22, 2008

Last Update Posted Date

Sep 23, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
#1	Experimental	Diabetes specific enteral feeding product	Other: Diabetes specific feeding product
#2	Active Comparator	Standard enteral feeding product	Other: standard enteral feeding product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard enteral feeding product	Other	16 hrs daily x 5 days	#2
Diabetes specific feeding product

Measure	Description	Time Frame
mean glucose level		24 hours

Measure	Description	Time Frame
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed and dated informed consent
diagnosis of type 2 diabetes
HbA1c between 7.0 and 9.0%
18 - 75 years of age
currently receiving a standard enteral product
anticipated duration on tube feeding at least one month
100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
anticipated life expectancy is more than or equal to 6 months
free of infections
no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion Criteria:

composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
significant cardiovascular event less than or equal to 2 weeks prior to study entry
major surgery less than or equal to 2 weeks prior to study entry
pre-planned surgery during the study period
active malignancy, including melanoma and excluding cutaneous malignancies
severe dementia
known allergies to medical grade adhesives and/or skin disinfectants
taking octreotide
chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
participation in a concomitant trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gordon Sacks, PhD	University of Wisconsin, Madison	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Segal Institute for Clinical Research		Miami	Florida	33161	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20470226	Derived	Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases