Evaluation of Glycemic Response in Individuals With Type 2 Diabetes

NCT05165693 | Completed

• 1 other identifier: BL60
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, crossover study to compare the effects to two treatments on postprandial glucose in adults with type 2 diabetes.

Conditions

Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Glucose positive area under the curve (AUC)

  Calculated from blood samples

  0 to 240 minutes

Secondary Outcomes (7)

• Insulin positive area under the curve (AUC)

  0 to 240 minutes

• Insulin peak value

  0 to 240 minutes

• Glucose peak value

  0 to 240 minutes

• Insulin peak time

  0 to 240 minutes

• Glucose peak time

  0 to 240 minutes

Other Outcomes (6)

• Glucagon-Like Peptide-1 (GLP-1) positive area under the curve (AUC)

  0 to 240 minutes

• Glucagon-Like Peptide-1 (GLP-1) peak value

  0 to 240 minutes

• Glucagon-Like Peptide-1 (GLP-1) peak time

  0 to 240 minutes

Study Arms (2)

Experimental Formula

EXPERIMENTAL

One 296 mL serving of study product

Other: Experimental Formula

Test Meal

ACTIVE COMPARATOR

48 g Instant oatmeal

Other: Test Meal

Interventions

Experimental Formula OTHER

Diabetes-specific study formula

Experimental Formula

Test Meal OTHER

Instant oatmeal

Test Meal

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 and ≤ 75 years
• Participant has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s) with constant dose for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.
• Participant with a BMI \> 18.5 and ≤ 40.0 kg/m2
• Participant is weight stable for the two months prior to the screening visit.
• Male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
• If the participant is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the dosage must be constant for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.
• Participant is willing to follow protocol as described, including consumption of study product per protocol and completing any forms needed throughout the study.
• Participant has at least a two-week washout period between completion of a previous research study that required ingestion of any study food or drug and Visit 2 when assigned study product is consumed.
• Participant is willing to refrain from taking non-study diabetes-specific formulas over the entire course of the study.
• Participant has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

You may not qualify if:

• Participant has a screening HbA1c level \< 7% or ≥ 10%.
• Participant uses exogenous insulin or GLP-1 agonists or DPP-4 inhibitors for glucose control.
• Participant has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
• Participant has current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks.
• Participant has active malignancy.
• Participant has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
• Participant has end stage organ failure or was post organ transplant.
• Participant has a history of renal disease or severe gastroparesis.
• Participant has current hepatic disease.
• Participant 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.
• Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV.
• Participant 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.
• Participant is 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.
• Participant uses diabetes-specific formula(s) defined as more than one eating occasion per week in the last three months.
• Participant has clotting or bleeding disorders. The use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws is allowed and participant is able to maintain medication number, type and dose throughout the duration of study.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Study Officials

• Sara Thomas, PhD, RDN

  Abbott Nutrition

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 21, 2021
• Study Start: February 23, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)