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

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enteral Nutrition Formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enteral Nutrition Formula 1

Enteral Nutrition Formula 2

Arm Description

Enteral Nutrition Formula

Enteral Nutrition Formula

Outcomes

Primary Outcome Measures

Area under the blood glucose curve (AUC 0-240)

Secondary Outcome Measures

Area under the insulin curves (AUC 0-240)
Insulinogenic index (Ins30/(Glu30))
AUC (0-30min) for insulin

Full Information

First Posted
September 8, 2016
Last Updated
October 10, 2016
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02898766
Brief Title
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Official Title
Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enteral Nutrition Formula 1
Arm Type
Active Comparator
Arm Description
Enteral Nutrition Formula
Arm Title
Enteral Nutrition Formula 2
Arm Type
Active Comparator
Arm Description
Enteral Nutrition Formula
Intervention Type
Other
Intervention Name(s)
Enteral Nutrition Formula
Primary Outcome Measure Information:
Title
Area under the blood glucose curve (AUC 0-240)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary Outcome Measure Information:
Title
Area under the insulin curves (AUC 0-240)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Title
Insulinogenic index (Ins30/(Glu30))
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Title
AUC (0-30min) for insulin
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States

12. IPD Sharing Statement

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

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