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

Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

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 Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Meal replacement

• Study Type: Interventional
• Enrollment (Actual): 13
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meal replacement A	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Active Comparator: Meal replacement B	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Active Comparator: Meal replacement C	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Active Comparator: Meal replacement D	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Active Comparator: Meal replacement E	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Active Comparator: Meal replacement F	Other: Meal replacement; The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the insulin curves (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
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: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): May 18, 2017
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: May 1, 2017

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: 16.11.US.HCN

Drug and device information, study documents

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