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Completed

NCT Number: NCT03155867

Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six 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/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg
  • Hematocrit levels within normal limits

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

Treatment and study plan

Meal replacement

Other

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

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 [Change in Ins30/Change in 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 Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Jul 2, 2017

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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