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Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01324921
First received: March 27, 2011
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Other: No breakfast/beverage only
Other: Breakfast
Other: 10004RF
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Positive AUC for plasma glucose concentration [ Time Frame: 0 to 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose concentrations [ Time Frame: 0 to 180 minutes ] [ Designated as safety issue: No ]
  • Positive AUC for serum insulin concentration [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: 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
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
 Other: 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
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
 Other: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. type 2 diabetes
  2. between 21 and 75 years of age
  3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
  4. BMI is > 18.5 kg/m2 and <35 kg/m2
  5. 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:

  1. Hemoglobin A1c value at screening of greater than or equal to 9%.
  2. Uses exogenous insulin or exenatide for glucose control.
  3. type 1 diabetes.
  4. history of diabetic ketoacidosis.
  5. 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.
  6. active malignancy
  7. significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
  8. end-stage organ failure or is status post organ transplant.
  9. history of renal disease.
  10. current hepatic disease.
  11. history of severe gastroparesis.
  12. chronic, contagious, infectious disease
  13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
  14. clotting or bleeding disorders
  15. allergic or intolerant to any ingredient found in the study products.
  16. habitual user of tobacco products (
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324921

Locations
United States, Illinois
Provident Clinical Research and Consulting LLC
Glen Ellyn, Illinois, United States, 60137
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Amy Devitt-Maicher, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01324921     History of Changes
Other Study ID Numbers: BK40
Study First Received: March 27, 2011
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013