Glycemic Response in Persons With Type 2 Diabetes Mellitus

NCT04168541 | Completed DMC

• 1 other identifier: 17.11.US.HCN
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Area under the insulin curves (AUC 0-240)

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

• Insulinogenic index [Change in Ins30/Change in Glu30]

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

Study Arms (6)

Oral Nutrition Supplement A

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Oral Nutrition Supplement B

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Oral Nutrition Supplement C

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Oral Nutrition Supplement D

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Oral Nutrition Supplement E

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Oral Nutrition Supplement F

ACTIVE COMPARATOR

Product containing calories from carbohydrate, protein, and fat

Other: Oral Nutrition Supplement

Interventions

Oral Nutrition Supplement OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement A; Oral Nutrition Supplement B; Oral Nutrition Supplement C; Oral Nutrition Supplement D; Oral Nutrition Supplement E; Oral Nutrition Supplement F

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Joel Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study staff will not be blinded to product assignment. Study participants will be blinded to product assignment. Product will be provided in unlabeled plastic 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 six interventions on six separate study days, one week apart.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: November 19, 2019
• Study Start: February 5, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: May 15, 2025

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)