Evaluation of Glycemic Response in Individuals With Type 2 Diabetes

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

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

Conditions
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Glycemic Control

Intervention / Treatment
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* Other: Experimental Formula
* Other: Test Meal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |