- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324921
Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
March 29, 2011 updated by: Abbott Nutrition
To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Glen Ellyn, Illinois, United States, 60137
- Provident Clinical Research and Consulting LLC
-
-
Ohio
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Cincinnati, Ohio, United States, 45249
- Radiant Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2 diabetes
- between 21 and 75 years of age
- male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- BMI is > 18.5 kg/m2 and <35 kg/m2
- If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.
Exclusion Criteria:
- Hemoglobin A1c value at screening of greater than or equal to 9%.
- Uses exogenous insulin or exenatide for glucose control.
- type 1 diabetes.
- history of diabetic ketoacidosis.
- current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- active malignancy
- significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- end-stage organ failure or is status post organ transplant.
- history of renal disease.
- current hepatic disease.
- history of severe gastroparesis.
- chronic, contagious, infectious disease
- taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
- clotting or bleeding disorders
- allergic or intolerant to any ingredient found in the study products.
- habitual user of tobacco products (
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: No breakfast/beverage only
12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
Active Comparator: Breakfast
1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
Experimental: 10004RF
1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive AUC for plasma glucose concentration
Time Frame: 0 to 180 minutes
|
0 to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma glucose concentrations
Time Frame: 0 to 180 minutes
|
0 to 180 minutes
|
Positive AUC for serum insulin concentration
Time Frame: 0-180 minutes
|
0-180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
March 27, 2011
First Submitted That Met QC Criteria
March 28, 2011
First Posted (Estimate)
March 29, 2011
Study Record Updates
Last Update Posted (Estimate)
March 30, 2011
Last Update Submitted That Met QC Criteria
March 29, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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