Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in Type 2 Diabetes

February 1, 2019 updated by: Daniel J Aparicio Camargo, Universidad del Zulia

Effect of the Intake of Specific Formulas for Diabetes With Sucromalt and Isomaltulose on the Glycemic Index, Insulin, Glucagon-like Peptide-1, Gastric Inhibitory Peptide Levels and Subjective Appetite in Subjects With Type 2 Diabetes

Consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking, after that they were given to consume formula or reference product assigned randomly. Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120 and 180 min, after the start of consumption of the experimental beverage for the measurement of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1). The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).

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.

Detailed Description

This was a randomized, double-blind, cross-over study of 4 treatments that was conducted according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy regulations, and ethical principles based on the Declaration of Helsinki. Participants signed informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic Research Center of the University of Zulia, in Venezuela. All selected subjects attended a first visit, in order to determine if they met the inclusion criteria, those who gathered them, were subjected to four consumption tests to determine the glycemic index (GI) and glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each treatment or consumption session was carried out on different days.

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.
23

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

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

51 years to 63 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes
  • Demonstrated use of oral hypoglycemic agents (metformin), for at least two months
  • BMI of 18.5 kg/m2 to ≤ 35 kg/m2

Exclusion Criteria:

  • Type 1 Diabetes
  • Diabetic ketoacidosis
  • Congestive heart failure
  • Gastric, renal or hepatic diseases
  • Myocardial infarction
  • Stroke
  • Subjects with insulin therapy, antibiotic therapy or corticosteroids
  • End-stage organ failure
  • Individuals with organ transplantation
  • Coagulation or bleeding disorder
  • Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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: Ensure® Abbott Nutrition
A standard nutritional formula not specific for diabetics
Dietary supplement: Ensure® Abbott Nutrition
Effect of the intake of Ensure® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
Experimental: Glucerna® Abbott Nutrition
A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
Dietary supplement: Glucerna® Abbott Nutrition
Effect of the intake of Glucerna® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
Experimental: Diasip® Nutricia Advanced
A formula whose composition has isomaltulose and resistant starch
Dietary supplement: Diasip® Nutricia Advanced
Effect of the intake of Diasip® Nutricia Advanced on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
Active Comparator: Glicolab®
Glucose solution
Dietary supplement: Glicolab®
Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes

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
Change from baseline Glycemia at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
mmol/L
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Insulin at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
milliunits per liter (mU/L)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Glycemic Index (GI)
Time Frame: 180 minutes after intake of each formula
Low GI (≤ 55), Intermediate (55-69) and High (≥70)
180 minutes after intake of each formula
Glycemic Load (GL)
Time Frame: 180 minutes after intake of each formula
High GL (> 20), Intermediate GL (11-19) and Low GL (<10)
180 minutes after intake of each formula
Change from baseline GLP-1 at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
pmol/L
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline GIP at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
pg/mL
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Hunger at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Fullness at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Desire to eat at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Prospective food consumption at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Change from baseline Subjective appetite at 180 minutes
Time Frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

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
Age
Time Frame: Baseline
years
Baseline
Weight
Time Frame: Baseline
kg
Baseline
Height
Time Frame: Baseline
m
Baseline
Body Mass Index
Time Frame: Baseline
kg/m^2
Baseline
Hip Circumference
Time Frame: Baseline
cm
Baseline
Total Cholesterol
Time Frame: Baseline
mg/dl
Baseline
HDL-C
Time Frame: Baseline
mg/dl
Baseline
LDL-C
Time Frame: Baseline
mg/dl
Baseline
Triacylglycerides
Time Frame: Baseline
mg/dl
Baseline
HbA1c
Time Frame: Baseline
percentage (%)
Baseline

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.
Universidad del Zulia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisse Angarita, PhD, Universidad Andrés Bello, Facultad de Medicina - Sede Concepción

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.
September 1, 2016

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.
September 1, 2017

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.
November 15, 2018

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).
January 28, 2019

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.
February 1, 2019

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.
February 4, 2019

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.
February 4, 2019

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.
February 1, 2019

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.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 1001092016

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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