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NCT04413357 | COMPLETED | Diabetes Mellitus, Type 2

Glycemic Response in Persons With Type 2 Diabetes
Sponsor:

Nestlé Products Company (SPN)

Brief Summary:

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

Condition or disease

Diabetes Mellitus, Type 2

Intervention/treatment

Balanced Nutritional Drink

Diabetes Specific, Balanced Nutritional Drink (DMA)

Diabetes Specific, Balanced Nutritional Drink DMB

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 14 participants
Masking : SINGLE
Masking Description : Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus
Actual Study Start Date : 2020-05-18
Estimated Primary Completion Date : 2020-06-11
Estimated Study Completion Date : 2020-08-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Glycemic Response in Persons With Type 2 Diabetes

Location Details

NCT04413357

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Orange County Research Center

I felt it, California, United States, 92780