Glycemic Response in Adults With Type 2 Diabetes

NCT ID: NCT05166200

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2022-06-20

Brief Summary

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

Conditions

Glycemic Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Formula

One 237 ml serving of study product

Group Type: EXPERIMENTAL

Experimental Formula

Intervention Type: OTHER

Diabetes-specific study formula

Test Meal

48 g Instant oatmeal

Group Type: ACTIVE_COMPARATOR

Test Meal

Intervention Type: OTHER

Instant oatmeal

Interventions

Experimental Formula

Diabetes-specific study formula

Intervention Type: OTHER

Test Meal

Instant oatmeal

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Participant participates in another study that has not been approved as a concomitant study by AN.
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the participant.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Thomas, PhD, RDN

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Finlay Medical Research

Miami, Florida, United States

Great Lakes Clinical Trials, LLC

Gurnee, Illinois, United States

Countries

United States

Other Identifiers

BL59

Identifier Type: -

Identifier Source: org_study_id