Postprandial Glycemic Response to a Diabetes-Specific Formula and Oatmeal in Adults With Type 2 Diabetes

Abbott Nutrition2 sites in 1 country26 target enrollmentMarch 11, 2022

ConditionsGlycemic Control

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glycemic Control
Sponsor: Abbott Nutrition
Enrollment: 26
Locations: 2
Primary Endpoint: Glucose positive area under the curve (AUC)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2022

End Date

June 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

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.