Glycemic Response to Two Enteral Formulas in Persons With... | NCT02898766

Studies
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

NCT02898766

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Enteral Nutrition 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

Sep 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

Start Date

Aug 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 13, 2016Estimated

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 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral Nutrition Formula 1	Active Comparator	Enteral Nutrition Formula	Other: Enteral Nutrition Formula
Enteral Nutrition Formula 2	Active Comparator	Enteral Nutrition Formula	Other: Enteral Nutrition Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Nutrition Formula	Other		Enteral Nutrition Formula 1 Enteral Nutrition Formula 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the blood glucose curve (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcomes

Measure	Description	Time Frame
Area under the insulin curves (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30))		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-75 yrs
Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
Hemoglobin A1C less than 9.0%
Fasting blood glucose less than 180 mg

Exclusion Criteria:

Abnormal thyroid function
Creatinine >2.0 mg/dL
Potassium <3.5 mEq/L
Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
Patients currently on any anti-coagulant medication
Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
Unable to give informed consent or follow instructions
Current insulin therapy or insulin therapy within the past month
Patient who are pregnant
Allergies to milk, fish oil or any component of the test product
Patient who in the Investigators assessment cannot be expected to comply with treatment
Currently participating or having participated in another clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Joel Neutel, MD	Orange County Research Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Orange County Research Center		Tustin	California	92780	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided