Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Not Applicable
Completed
- Conditions
- Diabetes
- Interventions
- Other: Meal replacement
- Registration Number
- NCT03155867
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meal replacement B Meal replacement - Meal replacement E Meal replacement - Meal replacement C Meal replacement - Meal replacement D Meal replacement - Meal replacement A Meal replacement - Meal replacement F Meal replacement -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Insulinogenic index [Change in Ins30/Change in Glu30] Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes 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
Trial Locations
- Locations (1)
Orange County Research Center
🇺🇸Tustin, California, United States