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OpenTrials
Completed

NCT Number: NCT00797069

Comparison of Nutritional Products for People With Type 2 Diabetes

Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinico San Carlos, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
  • Subject is between 18 and 75 years of age, inclusive.
  • Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
  • If female is of childbearing potential, is practicing a method of birth control.
  • Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
  • If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion criteria

  • Subject uses exogenous insulin for glucose control.
  • Subject states that he/she has type 1 diabetes.
  • Subject states that he/she has a history of diabetic ketoacidosis.
  • Subject takes an alpha-glucosidase inhibitor.
  • Subject states that he/she has a 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.
  • Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
  • Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
  • Subject states that he/she has end stage organ failure or is status post organ transplant.
  • Subject states that he/she has a history of renal disease.
  • Subject states that he/she has current hepatic disease.
  • Subject states that he/she has a history of severe gastroparesis.
  • Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
  • Subject states that he/she has clotting or bleeding disorders.
  • Subject is known to be allergic or intolerant to any ingredient found in the study products.

Treatment and study plan

standard nutritional product (medical food)

Other

once during crossover

nutritional product for diabetes (medical food)

Other

once during crossover

diabetes specific experimental nutritional product (medical food)

Other

once during crossover

Primary outcomes

  1. To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.

    Time frame: Three crossover periods

Secondary outcomes

  1. To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.

    Time frame: Three crossover periods

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2008
Registry last updated
Jul 30, 2010

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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