Diabetes-specific Formula (DSF) in Individuals With Type 2 Diabetes

A Randomized Controlled Trial to Determine the Effects of Diabetes-specific Formula on Glycemic Control in Individuals With Type 2 Diabetes

A randomized, controlled, crossover design with three treatments to determine the effects of diabetes-specific formula on glycemic control in individuals with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: DSF; Other: Breakfast 1; Other: Breakfast 2

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10330
    • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s).
2. BMI > 18.5 and ≤ 35.0 kg/m2.
3. Weight stable.
4. Male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
5. If on chronic medication, the dosage to be constant for at least two months prior to screening visit and to maintain the medication and dose throughout the study.
6. Willing to follow the protocol throughout the study.
7. At least a two-week washout period between completion of a previous research study and their start in the current study.
8. Willing to refrain from taking non-study diabetes-specific formulas over the course of the study.
9. Voluntarily signed and dated an Informed Consent Form (ICF) prior to any participation in the study.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Has a screening HbA1c level < 7% or ≥ 10%.
2. Uses exogenous insulin for glucose control.
3. Has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
4. Has current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks.
5. Has active malignancy.
6. Has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
7. Has end stage organ failure or was post organ transplant.
8. Has a history of renal disease or severe gastroparesis.
9. Has current hepatic disease.
10. Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product.
11. Has a chronic, contagious, infectious disease.
12. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
13. Taking any herbals, dietary supplements or medications other than allowed anti-hyperglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose or appetite.
14. Uses diabetes-specific formula(s) defined as more than one eating occasion per week in the last three months.
15. Has clotting or bleeding disorders.
16. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition.
17. Has allergy or intolerance to any ingredient in the study product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental: Diabetes-specific formula	Other: DSF; Diabetes-specific formula
Other: Experimental: Breakfast 1 Noodle Soup	Other: Breakfast 1; Noodle Soup
Other: Experimental: Breakfast 2 Glutinous rice	Other: Breakfast 2; Glutinous rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial blood glucose	Positive area under the curve (AUC) for blood glucose concentration from 0 to 180 minutes.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin	Positive area under the curve (AUC) for blood insulin concentration from 0 to 180 minutes.	3 hours
Appetite	Negative/Positive area under the curve (AUC) for each item of Appetite questionnaire from 0 to 180 minutes.	3 hours

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Agnes Siew Ling Tey, PhD, Abbott Nutrition R&D

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BL65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No