Clinical trial NCT05165693: Evaluation of Glycemic Response in Individuals With Type 2 Diabetes
Official title: Glycemic Response to a Diabetes-Specific Formula and Oatmeal in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Control
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Glucose positive area under the curve (AUC)
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Insulin positive area under the curve (AUC)
timeFrame: 0 to 240 minutes
measure: Insulin peak value
timeFrame: 0 to 240 minutes
measure: Glucose peak value
timeFrame: 0 to 240 minutes
measure: Insulin peak time
timeFrame: 0 to 240 minutes
measure: Glucose peak time
timeFrame: 0 to 240 minutes
measure: Glucose Concentrations
timeFrame: 0 to 240 minutes
measure: Insulin Concentrations
timeFrame: 0 to 240 minutes
Other outcomes:
measure: Glucagon-Like Peptide-1 (GLP-1) positive area under the curve (AUC)
timeFrame: 0 to 240 minutes
measure: Glucagon-Like Peptide-1 (GLP-1) peak value
timeFrame: 0 to 240 minutes
measure: Glucagon-Like Peptide-1 (GLP-1) peak time
timeFrame: 0 to 240 minutes
measure: Glucagon-Like Peptide-1 (GLP-1) concentrations
timeFrame: 0 to 240 minutes
measure: Appetite Questionnaire
timeFrame: Study Day 1 to Study Day 7
measure: Sensory Questionnaire
timeFrame: Study Day 1 to Study Day 7
Locations:
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
Study officials:
affiliation: Abbott Nutrition
name: Sara Thomas, PhD, RDN
role: STUDY_CHAIR
References: