Glycemic Response in Persons With Type 2 Diabetes

Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Balanced Nutritional Drink; Other: Diabetes Specific, Balanced Nutritional Drink (DMA); Other: Diabetes Specific, Balanced Nutritional Drink DMB

Detailed Description

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
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Balanced Nutritional Drink; The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.	Other: Balanced Nutritional Drink; Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
ACTIVE_COMPARATOR: Balanced Nutritional Drink - DMA; The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.	Other: Diabetes Specific, Balanced Nutritional Drink (DMA); 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.
ACTIVE_COMPARATOR: Balanced Nutritional Drink - DMB; The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.	Other: Diabetes Specific, Balanced Nutritional Drink DMB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the blood glucose curve	Area under the blood glucose curve (AUC 0-240 minutes)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the insulin curves	Area under the insulin curves (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index	Insulinogenic index [Change in Ins30/Change in Glu30]	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2020
• Primary Completion (ACTUAL): June 11, 2020
• Study Completion (ACTUAL): August 11, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19.01.US.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No