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

Société des Produits Nestlé (SPN)12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes

Interventions

Enteral Nutrition FormulaOTHER

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Orange County Research Center

Tustin, California, United States

Outcomes

Primary Outcomes

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 Outcomes

Area under the insulin curves (AUC 0-240)

Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Insulinogenic index (Ins30/(Glu30))

Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

AUC (0-30min) for insulin

Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Data from ClinicalTrials.gov

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