NCT05802927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

March 26, 2023

Last Update Submit

October 26, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood glucose

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

    3 hours

Secondary Outcomes (2)

  • Postprandial insulin

    3 hours

  • Appetite

    3 hours

Study Arms (3)

Experimental: Diabetes-specific formula

OTHER
Other: DSF

Experimental: Breakfast 1 Noodle Soup

OTHER
Other: Breakfast 1

Experimental: Breakfast 2 Glutinous rice

OTHER
Other: Breakfast 2

Interventions

DSFOTHER

Diabetes-specific formula

Experimental: Diabetes-specific formula
Breakfast 1OTHER

Noodle Soup

Experimental: Breakfast 1 Noodle Soup
Breakfast 2OTHER

Glutinous rice

Experimental: Breakfast 2 Glutinous rice

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Agnes Siew Ling Tey, PhD

    Abbott Nutrition R&D

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 7, 2023

Study Start

July 5, 2023

Primary Completion

October 26, 2023

Study Completion

October 26, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)