Glucose Response in Persons with Type 2 Diabetes

NCT04914559 | Completed

• 1 other identifier: 21.01.US.HCN
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized crossover design with oral 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 curve

  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 (2)

Oral Nutrition Supplement Control

ACTIVE COMPARATOR

The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.

Other: Oral nutrition supplement - control

Oral Nutrition Supplement Test

ACTIVE COMPARATOR

The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.

Other: Oral nutrition supplement - test

Interventions

Oral nutrition supplement - control OTHER

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

Oral Nutrition Supplement Control

Oral nutrition supplement - test 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.

Oral Nutrition Supplement Test

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/dl
• 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
• Patients with anemia
• 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
• Patients with anemia
• Currently participating in another clinical trial

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

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 two interventions on two separate study days, one week apart.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 4, 2021
• Study Start: May 17, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)