Glycemic ControlNCT05154045
Postprandial Glycemic Response in Adults With Type 2 Diabetes
A study testing Experimental Formula and Test Meal in people with Glycemic Control, run by Abbott Nutrition at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Glycemic Control
- What is being tested?
- Experimental Formula and Test Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Apr 2022to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Great Lakes Clinical Trials, LLC
Chicago, Illinois, 60640
Finlay Medical Research 3322
Greenacres City, Florida, 33467
Finlay Medical Research 3323
Miami, Florida, 33126
About this study
Official title: Postprandial Glycemic Response to a Diabetes-Specific Formula and Oatmeal in Individuals With Type 2 Diabetes
This is a randomized, controlled, crossover study to compare the effects of two treatments on postprandial glucose in adults with type 2 diabetes.
- Conditions
- Glycemic Control
- Being tested
- Experimental Formula, Test Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental FormulaOther
Diabetes-specific study formula
Test MealOther
Instant oatmeal
| Study group | Role | What they receive |
|---|---|---|
| Experimental Formula | Experimental | One 330 ml serving of study product Receives: Other: Experimental Formula |
| Test Meal | Active comparator | 40 g Instant oatmeal Receives: Other: Test Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose positive area under the curve (AUC)
Calculated from blood samples
Measured: 0 to 240 minutes
Secondary outcomes (7)
Insulin positive area under the curve (AUC)
Calculated from blood samples
Measured: 0 to 240 minutes
Insulin peak value
Calculated from blood samples
Measured: 0 to 240 minutes
Glucose peak value
Calculated from blood samples
Measured: 0 to 240 minutes
Insulin peak time
Calculated from blood samples
Measured: 0 to 240 minutes
Glucose peak time
Calculated from blood samples
Measured: 0 to 240 minutes
Insulin Concentrations
Calculated from blood samples
Measured: 0 to 240 minutes
Glucose Concentrations
Calculated from blood samples
Measured: 0 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start9 Apr 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Thomas, PhD, RDN, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154045
- Sponsor's protocol ID
- BL61
- Status last verified
- Jul 2022
- First submitted
- 29 Nov 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycemic Response to a Diabetes-Specific Formula and Oatmeal in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05154045
- Acronym / sponsor ID
- BL61
- Conditions
- Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled, crossover study to compare the effects of two treatments on postprandial glucose in adults with type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Formula | Experimental | Other: Experimental FormulaOne 330 ml serving of study product |
| Test Meal | Active comparator | Other: Test Meal40 g Instant oatmeal |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental FormulaDiabetes-specific study formula | Other | Experimental Formula |
| Test MealInstant oatmeal | Other | Test Meal |
Primary outcome
Glucose positive area under the curve (AUC)
Time frame: 0 to 240 minutes
Calculated from blood samples
7 secondary outcomes
Insulin positive area under the curve (AUC)
Time frame: 0 to 240 minutes
Insulin peak value
Time frame: 0 to 240 minutes
Glucose peak value
Time frame: 0 to 240 minutes
Insulin peak time
Time frame: 0 to 240 minutes
Glucose peak time
Time frame: 0 to 240 minutes
Insulin Concentrations
Time frame: 0 to 240 minutes
Glucose Concentrations
Time frame: 0 to 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Glycemic Control
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Thomas, PhD, RDN study chair
Abbott Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Formula and Test Meal in people with Glycemic Control, run by Abbott Nutrition at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose positive area under the curve (AUC) (time frame: 0 to 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.