Post Prandial Glucose Control Proof-of-Principle

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: #3 Nutritional ingredient + Fiber; Other: Nutritional ingredient; Other: #1 Nutritional ingredient +Fiber; Other: #2 Nutritional ingredient + Fiber; Other: Carbohydrate placebo

• Registration Number: NCT01326299
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Last Update Submitted: 2011-03-29
• Study First Posted: 2011-03-30
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
#3 Nutritional ingredient + Fiber	#3 Nutritional ingredient + Fiber	Dissolve in water and consume with meal
Nutritional ingredient	Nutritional ingredient	Dissolve in water and consume with meal
#1 Nutrtitional ingredient + Fiber	#1 Nutritional ingredient +Fiber	Dissolve in water and consume with meal
#2 Nutritional ingredient + Fiber	#2 Nutritional ingredient + Fiber	Dissolve in water and consume with meal
Carbohydrate	Carbohydrate placebo	dissolve in water and consume with meal

Primary Outcome Measures

Name	Time	Method
Positive AUC from 0 to 240 minutes for plasma glucose.	0 to 240 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma glucose concentrations	0 to 240 minutes

Trial Locations

Locations (1)

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States