Glycemic Response in Persons with Type 2 Diabetes

Société des Produits Nestlé (SPN)14 enrolled

Overview

This will be a randomized crossover design with nutrition supplement interventions.

This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Balanced Nutritional DrinkOTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.

Diabetes Specific, Balanced Nutritional Drink (DMA)OTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.

Diabetes Specific, Balanced Nutritional Drink DMBOTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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

Area under the blood glucose curve (AUC 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

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

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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