Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Société des Produits Nestlé (SPN)13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes

Interventions

Meal replacementOTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

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 alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset) * Hemoglobin A1C less than 9.0% * Fasting blood glucose less than 180 mg * Hematocrit levels within normal limits 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 * 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 (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 [Change in Ins30/Change in 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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