Glycemic Response in Persons With Type 2 Diabetes

Overview

This will be a randomized crossover design with nutrition supplement interventions.

Full Title of Study: “Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 15, 2020

Detailed Description

This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Interventions

  • Other: Oral Nutrition Supplement
    • The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.

Arms, Groups and Cohorts

  • Active Comparator: Oral Nutrition Supplement A
    • The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
  • Active Comparator: Oral Nutrition Supplement B
    • The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
  • Active Comparator: Oral Nutrition Supplement C
    • The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.

Clinical Trial Outcome Measures

Primary Measures

  • Area under the blood glucose curve
    • Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
    • Area under the blood glucose curve (AUC 0-240 minutes)

Secondary Measures

  • Area under the insulin curves
    • Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
    • Area under the insulin curves (AUC 0-240)
  • Insulinogenic index
    • Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
    • Insulinogenic index [Change in Ins30/Change in Glu30]

Participating in This Clinical Trial

Inclusion Criteria

  • Age 20-75 years
  • Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg
  • Hematocrit levels within normal limits
  • Having obtained his/her informed consent

Exclusion Criteria

  • Abnormal thyroid function
  • Creatinine >2.0 mg/dl
  • Potassium <3.5 mEq/l
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
  • 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, soy 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
  • Patients with anemia

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nestlé
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Krysmaru Araujo Torres, MD, Study Director, Nestle Health Science

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