Post Prandial Glucose Control Proof-of-Principle

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01326299
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Other: Carbohydrate placebo
Other: Nutritional ingredient
Other: #1 Nutritional ingredient +Fiber
Other: #2 Nutritional ingredient + Fiber
Other: #3 Nutritional ingredient + Fiber
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Prandial Glucose Control Proof-of-Principle

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Positive AUC from 0 to 240 minutes for plasma glucose. [ Time Frame: 0 to 240 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose concentrations [ Time Frame: 0 to 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 50
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
Active Comparator: Nutritional ingredient
Dissolve in water and consume with meal
Other: Nutritional ingredient
Dissolve in water and consume with meals
Placebo Comparator: Carbohydrate
dissolve in water and consume with meal
Other: Carbohydrate placebo
dissolve in water and consume with meal
Experimental: #1 Nutrtitional ingredient + Fiber
Dissolve in water and consume with meal
Other: #1 Nutritional ingredient +Fiber
Dissolve in water and consume with meal
Experimental: #2 Nutritional ingredient + Fiber
Dissolve in water and consume with meal
Other: #2 Nutritional ingredient + Fiber
Dissolve in water and consume with meal
Experimental: #3 Nutritional ingredient + Fiber
Dissolve in water and consume with meal
Other: #3 Nutritional ingredient + Fiber
Dissolve in water and consume with meal

  Eligibility

Ages Eligible for Study:   21 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. HbA1c < 9.0%

Exclusion Criteria:

  1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
  2. type 1 diabetes.
  3. history of diabetic ketoacidosis.
  4. current infection
  5. active malignancy
  6. has had a significant cardiovascular event or history of congestive heart failure.
  7. end-stage organ failure or post organ transplant.
  8. history of renal disease.
  9. hepatic disease.
  10. history of gastrointestinal disorders
  11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
  13. clotting or bleeding disorders.
  14. allergic or intolerant to any ingredient found in the study products.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326299

Locations
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: NCT01326299     History of Changes
Other Study ID Numbers: BK92
Study First Received: March 28, 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 October 19, 2014