Evaluation of Glycemic Response in Individuals With Type 2 Diabetes

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

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

Study Overview

• Status: Completed
• Conditions: Glycemic Control
• Intervention / Treatment: Other: Experimental Formula; Other: Test Meal

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Formula; One 296 mL serving of study product	Other: Experimental Formula; Diabetes-specific study formula
Active Comparator: Test Meal; 48 g Instant oatmeal	Other: Test Meal; Instant oatmeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose positive area under the curve (AUC)	Calculated from blood samples	0 to 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin positive area under the curve (AUC)	Calculated from blood samples	0 to 240 minutes
Insulin peak value	Calculated from blood samples	0 to 240 minutes
Glucose peak value	Calculated from blood samples	0 to 240 minutes
Insulin peak time	Calculated from blood samples	0 to 240 minutes
Glucose peak time	Calculated from blood samples	0 to 240 minutes
Glucose Concentrations	Calculated from blood samples	0 to 240 minutes
Insulin Concentrations	Calculated from blood samples	0 to 240 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucagon-Like Peptide-1 (GLP-1) positive area under the curve (AUC)	Calculated from blood samples	0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) peak value	Calculated from blood samples	0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) peak time	Calculated from blood samples	0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) concentrations	Calculated from blood samples	0 to 240 minutes
Appetite Questionnaire	5 Visual analog scales; Including Score from Not at All to Extremely or Nothing to Most	Study Day 1 to Study Day 7
Sensory Questionnaire	10 sensory and hedonic questions; Up to 9-Point Likert Scale questions including Dislike Extremely to Like Extremely or Much too to Much Lass or Not as all to Extremely	Study Day 1 to Study Day 7

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BL60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No