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OpenTrials
Completed

NCT Number: NCT01324921

Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Provident Clinical Research and Consulting LLC, Glen Ellyn, Illinois, United States

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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
  • If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.

Exclusion criteria

  • Hemoglobin A1c value at screening of greater than or equal to 9%.
  • Uses exogenous insulin or exenatide for glucose control.
  • type 1 diabetes.
  • history of diabetic ketoacidosis.
  • current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
  • active malignancy
  • significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
  • end-stage organ failure or is status post organ transplant.
  • history of renal disease.
  • current hepatic disease.
  • history of severe gastroparesis.
  • chronic, contagious, infectious disease
  • taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
  • clotting or bleeding disorders
  • allergic or intolerant to any ingredient found in the study products.
  • habitual user of tobacco products (

Treatment and study plan

No breakfast/beverage only

Other

12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener

Breakfast

Other

1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener

10004RF

Other

1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener

Primary outcomes

  1. Positive AUC for plasma glucose concentration

    Time frame: 0 to 180 minutes

Secondary outcomes

  1. Plasma glucose concentrations

    Time frame: 0 to 180 minutes

  2. Positive AUC for serum insulin concentration

    Time frame: 0-180 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 29, 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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