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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802927
• Other study ID #: BL65
• Status: Completed
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: October 2023
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• DSF
Diabetes-specific formula
• Breakfast 1
Noodle Soup
• Breakfast 2
Glutinous rice

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose	Positive area under the curve (AUC) for blood glucose concentration from 0 to 180 minutes.	3 hours
Secondary	Postprandial insulin	Positive area under the curve (AUC) for blood insulin concentration from 0 to 180 minutes.	3 hours
Secondary	Appetite	Negative/Positive area under the curve (AUC) for each item of Appetite questionnaire from 0 to 180 minutes.	3 hours