search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
DSF
Breakfast 1
Breakfast 2
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s). BMI > 18.5 and ≤ 35.0 kg/m2. Weight stable. Male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 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. Willing to follow the protocol throughout the study. At least a two-week washout period between completion of a previous research study and their start in the current study. Willing to refrain from taking non-study diabetes-specific formulas over the course of the study. 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: Has a screening HbA1c level < 7% or ≥ 10%. Uses exogenous insulin for glucose control. Has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis. Has current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks. Has active malignancy. Has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure. Has end stage organ failure or was post organ transplant. Has a history of renal disease or severe gastroparesis. Has current hepatic disease. 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. Has a chronic, contagious, infectious disease. 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. 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. Uses diabetes-specific formula(s) defined as more than one eating occasion per week in the last three months. Has clotting or bleeding disorders. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition. Has allergy or intolerance to any ingredient in the study product.

Sites / Locations

  • Chulalongkorn UniversityRecruiting
  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Experimental: Diabetes-specific formula

Experimental: Breakfast 1 Noodle Soup

Experimental: Breakfast 2 Glutinous rice

Arm Description

Outcomes

Primary Outcome Measures

Postprandial blood glucose
Positive area under the curve (AUC) for blood glucose concentration from 0 to 180 minutes.

Secondary Outcome Measures

Postprandial insulin
Positive area under the curve (AUC) for blood insulin concentration from 0 to 180 minutes.
Appetite
Negative/Positive area under the curve (AUC) for each item of Appetite questionnaire from 0 to 180 minutes.

Full Information

First Posted
March 26, 2023
Last Updated
July 7, 2023
Sponsor
Abbott Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT05802927
Brief Title
Diabetes-specific Formula (DSF) in Individuals With Type 2 Diabetes
Official Title
A Randomized Controlled Trial to Determine the Effects of Diabetes-specific Formula on Glycemic Control in Individuals With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Diabetes-specific formula
Arm Type
Other
Arm Title
Experimental: Breakfast 1 Noodle Soup
Arm Type
Other
Arm Title
Experimental: Breakfast 2 Glutinous rice
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
DSF
Intervention Description
Diabetes-specific formula
Intervention Type
Other
Intervention Name(s)
Breakfast 1
Intervention Description
Noodle Soup
Intervention Type
Other
Intervention Name(s)
Breakfast 2
Intervention Description
Glutinous rice
Primary Outcome Measure Information:
Title
Postprandial blood glucose
Description
Positive area under the curve (AUC) for blood glucose concentration from 0 to 180 minutes.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Postprandial insulin
Description
Positive area under the curve (AUC) for blood insulin concentration from 0 to 180 minutes.
Time Frame
3 hours
Title
Appetite
Description
Negative/Positive area under the curve (AUC) for each item of Appetite questionnaire from 0 to 180 minutes.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s). BMI > 18.5 and ≤ 35.0 kg/m2. Weight stable. Male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 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. Willing to follow the protocol throughout the study. At least a two-week washout period between completion of a previous research study and their start in the current study. Willing to refrain from taking non-study diabetes-specific formulas over the course of the study. 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: Has a screening HbA1c level < 7% or ≥ 10%. Uses exogenous insulin for glucose control. Has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis. Has current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks. Has active malignancy. Has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure. Has end stage organ failure or was post organ transplant. Has a history of renal disease or severe gastroparesis. Has current hepatic disease. 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. Has a chronic, contagious, infectious disease. 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. 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. Uses diabetes-specific formula(s) defined as more than one eating occasion per week in the last three months. Has clotting or bleeding disorders. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition. Has allergy or intolerance to any ingredient in the study product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Qi Mak, BSc
Phone
+65 6801 6272
Email
meiqi.mak@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Siew Ling Tey, PhD
Organizational Affiliation
Abbott Nutrition R&D
Official's Role
Study Chair
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs