Glycemic Response in Persons with Type 2 Diabetes

NCT04413357 | Completed

• 1 other identifier: 19.01.US.HCN
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Area under the blood glucose curve

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

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

Secondary Outcomes (2)

• Area under the insulin curves

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

• Insulinogenic index

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

Study Arms (3)

Balanced Nutritional Drink

ACTIVE COMPARATOR

The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.

Other: Balanced Nutritional Drink

Balanced Nutritional Drink - DMA

ACTIVE COMPARATOR

The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.

Other: Diabetes Specific, Balanced Nutritional Drink (DMA)

Balanced Nutritional Drink - DMB

ACTIVE COMPARATOR

The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.

Other: Diabetes Specific, Balanced Nutritional Drink DMB

Interventions

Balanced Nutritional Drink OTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.

Balanced Nutritional Drink

Diabetes Specific, Balanced Nutritional Drink (DMA) OTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.

Balanced Nutritional Drink - DMA

Diabetes Specific, Balanced Nutritional Drink DMB OTHER

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.

Balanced Nutritional Drink - DMB

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

HLA-DM antigens

Condition Hierarchy (Ancestors)

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

Study Officials

• Krysmaru Araujo Torres, MD

  Nestle Health Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: May 18, 2020
• Primary Completion: June 11, 2020
• Study Completion: August 11, 2020
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)