Diabetes-Specific Formula on Long Term Glycemic Control

NCT04345497 | Completed

• 1 other identifier: BL46
• Study Type: interventional
• Target: 251
• Locations: 2 countries
• Sites: 5

Brief Summary

The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Level

  Change in HbA1c level from Day 0 to Day 90

  Study Days 0, 45 and 90

Secondary Outcomes (5)

• Glycemic Excursion

  Study Day 1 to Day 7

• Glucose

  Study Day 1 to Day 7

• Time of glucose level

  Study Day 1 to Day 7

• Hypoglycemic Episodes

  Study Day 1 to Day 7

• Hyperglycemic Episodes

  Study Day 1 to Day 7

Study Arms (2)

Diabetes-Specific Formula

EXPERIMENTAL

Diabetes-specific formula 1-2 servings a day and Standard of Care

Other: Diabetes-Specific Formula

Standard of Care

OTHER

Standard of Care

Other: Standard Of Care

Interventions

Diabetes-Specific Formula OTHER

Diabetes-Specific Formula and Standard of Care

Diabetes-Specific Formula

Standard Of Care OTHER

Standard of Care

Standard of Care

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants (≥ 21 and ≤ 65 years of age)
• Has type 2 diabetes as evidenced with oral anti-diabetic drug(s) at constant dose for at least two months prior to the study and is able to maintain number of medications, type and dose throughout the duration of the study
• BMI ≥ 23 and \< 35.0 kg/m2
• Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit
• Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the Baseline Visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• If the female is of childbearing potential, she is practicing one of the following methods of birth control and will continue through the duration of the study:
• Condoms, sponge, diaphragm or intrauterine device;
• Oral or parenteral contraceptives for 3 months prior to Baseline Visit;
• Vasectomized partner;
• Total abstinence from sexual intercourse
• If on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the medication number, type and dose were constant for at least two months prior to the Baseline Visit and will continue through the duration of the study
• Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study
• At least a two-week washout period is needed between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study
• The participant is willing to refrain from taking non-study diabetes-specific formulas over the entire course of the study

You may not qualify if:

• Screening HbA1c level \<7% or ≥ 10%
• Use of exogenous insulin for glucose control
• Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis
• Current infection (requiring medication), inpatient surgery or received systemic corticosteroid treatment \[except for inhaled (includes nasal), topical, and ophthalmic steroids\] in the last 3 months; or received antibiotics in the last 3 weeks
• Active malignancy within the last 5 years
• A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure
• End-stage organ failure (such as end-stage renal disease) or is post-organ transplant
• Current or history of renal disease or on dialysis or severe gastroparesis
• Current hepatic disease
• Has had bariatric surgery including gastric balloon; the history of gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that can interfere with consumption or digestion or absorption of study product
• A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
• 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 in the opinion of the principal investigator or study physician
• Taking any herbals, dietary supplements, or medications during the past four weeks prior to Baseline Visit that could profoundly affect (in the opinion of the primary investigator) blood glucose or appetite (e.g. orlistat, contrive, qsymia, belviq, incretins, cannabis, glucocorticoids, nicotinic acid, etc.) per healthcare professional's opinion
• Using diabetes-specific formula(s), (e.g. Glucerna, Nestle Nutren Diabetes, Kalbe Diabetasol, Appeton Nutrition Wellness 60+ Diabetic, ForSure, Penta Sure DM, Resurge DM, Diben, Diasip, etc.) defined as more than one eating occasion per week within the past 3 months (those users who have stopped using such products for more than 3 months may not be excluded)
• Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed)

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (5)

International Medical University

Kuala Lumpur, 57000, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Klinik Kesihatan Seremban

Seremban, 70300, Malaysia

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Agnes Siew Ling Tey, Ph.D.

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Determine the effects of a diabetes-specific formula \[1-2 servings per day as a (partial) meal replacement\] in addition to standard of care on HbA1c level, in comparison with the standard of care only

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: August 26, 2020
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

TH (2); MY (3)