Post Prandial Glucose Control Proof-of-Principle

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Nutritional ingredient; Other: Carbohydrate placebo; Other: #1 Nutritional ingredient +Fiber; Other: #2 Nutritional ingredient + Fiber; Other: #3 Nutritional ingredient + Fiber

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive AUC from 0 to 240 minutes for plasma glucose.	0 to 240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma glucose concentrations	0 to 240 minutes

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

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 28, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (ESTIMATE): March 30, 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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BK92