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Completed

NCT Number: NCT01326299

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.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Radiant Research

Cincinnati, Ohio, 45249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes
  • between 21 and 75 years of age
  • male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
  • BMI is > 18.5 kg/m2 and <35 kg/m2
  • HbA1c < 9.0%

Exclusion criteria

  • Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
  • type 1 diabetes.
  • history of diabetic ketoacidosis.
  • current infection
  • active malignancy
  • has had a significant cardiovascular event or history of congestive heart failure.
  • end-stage organ failure or post organ transplant.
  • history of renal disease.
  • hepatic disease.
  • history of gastrointestinal disorders
  • chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
  • clotting or bleeding disorders.
  • allergic or intolerant to any ingredient found in the study products.

Treatment and study plan

Carbohydrate placebo

Other

dissolve in water and consume with meal

Nutritional ingredient

Other

Dissolve in water and consume with meals

#1 Nutritional ingredient +Fiber

Other

Dissolve in water and consume with meal

#2 Nutritional ingredient + Fiber

Other

Dissolve in water and consume with meal

#3 Nutritional ingredient + Fiber

Other

Dissolve in water and consume with meal

Primary outcomes

  1. Positive AUC from 0 to 240 minutes for plasma glucose.

    Time frame: 0 to 240 minutes

Secondary outcomes

  1. Plasma glucose concentrations

    Time frame: 0 to 240 minutes

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2011
Registry last updated
Mar 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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