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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155867
• Other study ID #: 16.11.US.HCN
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: June 29, 2017
• Start date: April 5, 2017
• Est. completion date: May 18, 2017

Study information

• Verified date: May 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 18, 2017
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Meal replacement
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Locations

Country	Name	City	State
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the blood glucose curve (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary	Area under the insulin curves (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary	Insulinogenic index [Change in Ins30/Change in Glu30]		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary	AUC (0-30min) for insulin		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes