AzTrials
AzTrials

Diabetes Mellitus, Type 2NCT03829800

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

A study testing Ensure® Abbott Nutrition, Glucerna® Abbott Nutrition and Diasip® Nutricia Advanced in people with Diabetes Mellitus, Type 2, run by Universidad del Zulia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 51 to 63 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Ensure® Abbott Nutrition, Glucerna® Abbott Nutrition and Diasip® Nutricia Advanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
No sites listed yet
Study dates
1 Sep 2016to 15 Nov 2018
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 51 to 63 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Type 1 Diabetes
  • Diabetic ketoacidosis
  • Congestive heart failure
  • Gastric, renal or hepatic diseases
  • Myocardial infarction
  • Stroke
Show all 11Show fewer
  • 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).

About this study

Official title: 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).

Read the 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.

Being tested
Ensure® Abbott Nutrition, Glucerna® Abbott Nutrition, Diasip® Nutricia Advanced, Glicolab®
Keywords
Glycemic Index, Insulin, Incretins, Diabetes Mellitus type 2, Subjective appetite, Nutritional formula
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ensure® Abbott NutritionDietary supplement

    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

  • Glucerna® Abbott NutritionDietary supplement

    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

  • Diasip® Nutricia AdvancedDietary supplement

    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

  • Glicolab®Dietary supplement

    Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes

Study groups in NCT03829800
Study groupRoleWhat they receive
Ensure® Abbott NutritionExperimentalA standard nutritional formula not specific for diabetics
Receives: Dietary Supplement: Ensure® Abbott Nutrition
Glucerna® Abbott NutritionExperimentalA formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
Receives: Dietary Supplement: Glucerna® Abbott Nutrition
Diasip® Nutricia AdvancedExperimentalA formula whose composition has isomaltulose and resistant starch
Receives: Dietary Supplement: Diasip® Nutricia Advanced
Glicolab®Active comparatorGlucose solution
Receives: Dietary Supplement: Glicolab®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Glycemia at 180 minutes

    mmol/L

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  2. Change from baseline Insulin at 180 minutes

    milliunits per liter (mU/L)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  3. Glycemic Index (GI)

    Low GI (≤ 55), Intermediate (55-69) and High (≥70)

    Measured: 180 minutes after intake of each formula

  4. Glycemic Load (GL)

    High GL (> 20), Intermediate GL (11-19) and Low GL (<10)

    Measured: 180 minutes after intake of each formula

  5. Change from baseline GLP-1 at 180 minutes

    pmol/L

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  6. Change from baseline GIP at 180 minutes

    pg/mL

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  7. Change from baseline Hunger at 180 minutes

    Visual Analogue Scale (mm)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  8. Change from baseline Fullness at 180 minutes

    Visual Analogue Scale (mm)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  9. Change from baseline Desire to eat at 180 minutes

    Visual Analogue Scale (mm)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  10. Change from baseline Prospective food consumption at 180 minutes

    Visual Analogue Scale (mm)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

  11. Change from baseline Subjective appetite at 180 minutes

    Visual Analogue Scale (mm)

    Measured: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

Secondary outcomes (10)

  1. Age

    years

    Measured: Baseline

  2. Weight

    kg

    Measured: Baseline

  3. Height

    m

    Measured: Baseline

  4. Body Mass Index

    kg/m^2

    Measured: Baseline

  5. Hip Circumference

    cm

    Measured: Baseline

  6. Total Cholesterol

    mg/dl

    Measured: Baseline

  7. HDL-C

    mg/dl

    Measured: Baseline

  8. LDL-C

    mg/dl

    Measured: Baseline

  9. Triacylglycerides

    mg/dl

    Measured: Baseline

  10. HbA1c

    percentage (%)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start1 Sep 2016
  3. Primary completion1 Sep 2017
  4. Study completion15 Nov 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829800
Sponsor's protocol ID
1001092016
Status last verified
Feb 2019
First submitted
28 Jan 2019
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ensure® Abbott Nutrition, Glucerna® Abbott Nutrition and Diasip® Nutricia Advanced in people with Diabetes Mellitus, Type 2, run by Universidad del Zulia.

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 3 inclusion and 11 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Change from baseline Glycemia at 180 minutes (time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03829800.

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 4 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in