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OpenTrials
Completed

NCT Number: NCT00540488

Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.

Completed

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Protocare Trials, Chicago Center for Clinical Research, Chicago, Illinois, United States

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Who can participate

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

Inclusion criteria

  • signed and dated informed consent
  • 18-75 years of age
  • history of type 2 diabetes
  • males and non-pregnant, non-lactating females

Exclusion criteria

  • subject uses insulin for glucose control
  • significant cardiovascular event <12 weeks prior to study entry
  • active malignancies
  • history of end stage renal disease
  • history of organ transplant
  • current hepatic disease
  • intervention for HIB
  • takes niacin
  • history of gastroparesis
  • active disease that may interfere with nutrient intake
  • allergy or intolerance to ingredients in the study products

Treatment and study plan

Adult enteral formula

Other

Primary outcomes

  1. Adjusted area under the curve (adj-AUC) of glucose response

    Time frame: 0-240 minutes

Secondary outcomes

  1. Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance

    Time frame: 0 - 240 minutes

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula

Important dates

Study start
2002
First posted
Oct 8, 2007
Registry last updated
Oct 15, 2007

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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