Glycemic Response in Adults With Type 2 Diabetes

June 27, 2022 updated by: Abbott Nutrition

Postprandial 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 of two treatments on postprandial glucose in adults with type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Great Lakes Clinical Trials, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental Formula
One 237 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glucose positive area under the curve (AUC)
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin positive area under the curve (AUC)
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Insulin peak value
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucose peak value
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Insulin peak time
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucose peak time
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucose Concentrations
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Insulin Concentrations
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glucagon-Like Peptide-1 (GLP-1) peak value
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) peak time
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) concentrations
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Glucagon-Like Peptide-1 (GLP-1) positive area under the curve
Time Frame: 0 to 240 minutes
Calculated from blood samples
0 to 240 minutes
Appetite Questionnaire
Time Frame: Study Day 1 to Study Day 7
5 Visual analog scales; Including Score from Not al All to Extremely or Nothing to Most
Study Day 1 to Study Day 7
Sensory Questionnaire
Time Frame: Study Day 1 to Study Day 7
10 sensor 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL59

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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