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Post Prandial Glucose Control Proof-of-Principle

NCT ID: NCT01326299

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nutritional ingredient

Dissolve in water and consume with meal

Group Type ACTIVE_COMPARATOR

Nutritional ingredient

Intervention Type OTHER

Dissolve in water and consume with meals

Carbohydrate

dissolve in water and consume with meal

Group Type PLACEBO_COMPARATOR

Carbohydrate placebo

Intervention Type OTHER

dissolve in water and consume with meal

#1 Nutrtitional ingredient + Fiber

Dissolve in water and consume with meal

Group Type EXPERIMENTAL

#1 Nutritional ingredient +Fiber

Intervention Type OTHER

Dissolve in water and consume with meal

#2 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

Group Type EXPERIMENTAL

#2 Nutritional ingredient + Fiber

Intervention Type OTHER

Dissolve in water and consume with meal

#3 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

Group Type EXPERIMENTAL

#3 Nutritional ingredient + Fiber

Intervention Type OTHER

Dissolve in water and consume with meal

Interventions

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Carbohydrate placebo

dissolve in water and consume with meal

Intervention Type OTHER

Nutritional ingredient

Dissolve in water and consume with meals

Intervention Type OTHER

#1 Nutritional ingredient +Fiber

Dissolve in water and consume with meal

Intervention Type OTHER

#2 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

Intervention Type OTHER

#3 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Nutrition

Principal Investigators

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Amy Devitt-Maicher, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Radiant Research

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BK92

Identifier Type: -

Identifier Source: org_study_id