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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05154045
Other study ID # BL61
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2022
Est. completion date July 12, 2022

Study information

Verified date July 2022
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 12, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental Formula
Diabetes-specific study formula
Test Meal
Instant oatmeal

Locations

Country Name City State
United States Great Lakes Clinical Trials, LLC Chicago Illinois
United States Finlay Medical Research 3322 Greenacres City Florida
United States Finlay Medical Research 3323 Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Glucagon-Like Peptide-1 (GLP-1) positive area under the curve (AUC) Calculated from blood samples 0 to 240 minutes
Other Glucagon-Like Peptide-1 (GLP-1) peak value Calculated from blood samples 0 to 240 minutes
Other Glucagon-Like Peptide-1 (GLP-1) peak time Calculated from blood samples 0 to 240 minutes
Other Glucagon-Like Peptide-1 (GLP-1) Concentrations Calculated from blood samples 0 to 240 minutes
Other 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
Other 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 less or Not at all to Extremely Study Day 1 to Study Day 7
Primary Glucose positive area under the curve (AUC) Calculated from blood samples 0 to 240 minutes
Secondary Insulin positive area under the curve (AUC) Calculated from blood samples 0 to 240 minutes
Secondary Insulin peak value Calculated from blood samples 0 to 240 minutes
Secondary Glucose peak value Calculated from blood samples 0 to 240 minutes
Secondary Insulin peak time Calculated from blood samples 0 to 240 minutes
Secondary Glucose peak time Calculated from blood samples 0 to 240 minutes
Secondary Insulin Concentrations Calculated from blood samples 0 to 240 minutes
Secondary Glucose Concentrations Calculated from blood samples 0 to 240 minutes
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