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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT03155867
First received: May 15, 2017
Last updated: June 29, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Diabetes Other: Meal replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 13
Actual Study Start Date: April 5, 2017
Study Completion Date: May 18, 2017
Primary Completion Date: May 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03155867

Locations
United States, California
Orange County Research Center
Tustin, California, United States, 92780
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Joel Neutel, MD Orange County Research Center
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03155867     History of Changes
Other Study ID Numbers: 16.11.US.HCN
Study First Received: May 15, 2017
Last Updated: June 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2017