Glucose/Insulin Responses:Subjects With Type 2 Diabetes C... | NCT00540488

Studies
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

NCT00540488

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Oct 15, 2007Estimated

Enrollment

54Actual

Phase

Phase 3

Conditions

Diabetes Mellitus Type 2

Interventions

Adult enteral formula

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

Oct 2007

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

Aug 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 5, 2007

First Posted Date

Oct 8, 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

Oct 12, 2007

Last Update Posted Date

Oct 15, 2007Estimated

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Name	Type	Description	Arm Group Labels	Other Names
Adult enteral formula	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted area under the curve (adj-AUC) of glucose response		0-240 minutes

Secondary Outcomes

Measure	Description	Time Frame
Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance		0 - 240 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed and dated informed consent
18-75 years of age
history of type 2 diabetes
males and non-pregnant, non-lactating females

Exclusion Criteria:

subject uses insulin for glucose control
significant cardiovascular event <12 weeks prior to study entry
active malignancies
history of end stage renal disease
history of organ transplant
current hepatic disease
intervention for HIB
takes niacin
history of gastroparesis
active disease that may interfere with nutrient intake
allergy or intolerance to ingredients in the study products

Accepts Healthy Volunteers

Not provided

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolyn Alish, PhD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Protocare Trials, Chicago Center for Clinical Research		Chicago	Illinois	60610	United States
Medical University of South Carolina

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided