Glycemic Response to Three Oral Nutrition Supplements 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 three interventions on three separate study days, 1 week apart.

Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes

Interventions

Boost Glucose Control (A)OTHER

Oral nutrition supplement

Boost Glucose Control (B)OTHER

Oral nutrition supplement

Boost OriginalOTHER

Oral nutrition supplement

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/Glucotrol XL) 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 * 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 * Patients who are pregnant * Allergies to milk, soy 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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