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OpenTrials
Completed

NCT Number: NCT04168541

Glycemic Response in Persons With Type 2 Diabetes Mellitus

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

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Key information

Conditions

Diabetes Mellitus, Type 2 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.

Subject inclusion criteria

All subjects must comply with all the following 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

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

  • 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

Treatment and study plan

Oral Nutrition Supplement

Other

Product intake of oral nutrition supplement provided

Primary outcomes

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

    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 [Change in Ins30/Change in Glu30]

    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 Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
May 15, 2025

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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