Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
NCT ID: NCT03155867
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2017-04-05
2017-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Meal replacement A
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Meal replacement B
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Meal replacement C
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Meal replacement D
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Meal replacement E
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Meal replacement F
Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Interventions
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Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Neutel, MD
Role: PRINCIPAL_INVESTIGATOR
Orange County Research Center
Locations
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Orange County Research Center
Tustin, California, United States
Countries
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Other Identifiers
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16.11.US.HCN
Identifier Type: -
Identifier Source: org_study_id
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