Glycemic Response in Persons With Type 2 Diabetes Mellitus

Société des Produits Nestlé (SPN)14 enrolled

Overview

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Oral Nutrition SupplementOTHER

Product intake of oral nutrition supplement provided

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Subject inclusion criteria All subjects must comply with all the following inclusion criteria: * Age 20-75 years * Type 2 diabetes controlled with diet or diet and metformin (Glucophage) * Hemoglobin A1C less than 9.0% * Fasting blood glucose less than 180 mg * Hematocrit levels within normal limits * Having obtained his/her informed consent Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study. * 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 * Patient 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 * Patients with anemia

Locations (1)

Orange County Research Center

Tustin, California, United States

Outcomes

Primary Outcomes

Area under the blood glucose curve (ACU 0-240 minutes)

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 [Change in Ins30/Change in Glu30]

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

Data from ClinicalTrials.gov

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