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Completed

NCT Number: NCT02898766

Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orange County Research Center

Tustin, California, 92780, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20-75 yrs
  • Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg

Exclusion criteria

  • Abnormal thyroid function
  • Creatinine >2.0 mg/dL
  • Potassium <3.5 mEq/L
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
  • History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
  • Patients currently on any anti-coagulant medication
  • Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
  • Unable to give informed consent or follow instructions
  • Current insulin therapy or insulin therapy within the past month
  • Patient who are pregnant
  • Allergies to milk, fish oil or any component of the test product
  • Patient who in the Investigators assessment cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial.

Treatment and study plan

Enteral Nutrition Formula

Other

Primary outcomes

  1. Area under the blood glucose curve (AUC 0-240)

    Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary outcomes

  1. Area under the insulin curves (AUC 0-240)

    Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

  2. Insulinogenic index (Ins30/(Glu30))

    Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

  3. AUC (0-30min) for insulin

    Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2016
Registry last updated
Oct 11, 2016

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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