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

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ClinicalTrials.gov Identifier: NCT03155867
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Other: Meal replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : May 18, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 :
  1. Area under the insulin curves (AUC 0-240) [ Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes ]
  2. Insulinogenic index [Change in Ins30/Change in Glu30] [ Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes ]
  3. AUC (0-30min) for insulin [ Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03155867     History of Changes
Other Study ID Numbers: 16.11.US.HCN
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: May 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