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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ensure® Abbott Nutrition
Glucerna® Abbott Nutrition
Diasip® Nutricia Advanced
Glicolab®
Sponsored by
Universidad del Zulia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Glycemic Index, Insulin, Incretins, Diabetes Mellitus type 2, Subjective appetite, Nutritional formula

Eligibility Criteria

51 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Ensure® Abbott Nutrition

    Glucerna® Abbott Nutrition

    Diasip® Nutricia Advanced

    Glicolab®

    Arm Description

    A standard nutritional formula not specific for diabetics

    A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt

    A formula whose composition has isomaltulose and resistant starch

    Glucose solution

    Outcomes

    Primary Outcome Measures

    Change from baseline Glycemia at 180 minutes
    mmol/L
    Change from baseline Insulin at 180 minutes
    milliunits per liter (mU/L)
    Glycemic Index (GI)
    Low GI (≤ 55), Intermediate (55-69) and High (≥70)
    Glycemic Load (GL)
    High GL (> 20), Intermediate GL (11-19) and Low GL (<10)
    Change from baseline GLP-1 at 180 minutes
    pmol/L
    Change from baseline GIP at 180 minutes
    pg/mL
    Change from baseline Hunger at 180 minutes
    Visual Analogue Scale (mm)
    Change from baseline Fullness at 180 minutes
    Visual Analogue Scale (mm)
    Change from baseline Desire to eat at 180 minutes
    Visual Analogue Scale (mm)
    Change from baseline Prospective food consumption at 180 minutes
    Visual Analogue Scale (mm)
    Change from baseline Subjective appetite at 180 minutes
    Visual Analogue Scale (mm)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 28, 2019
    Last Updated
    February 1, 2019
    Sponsor
    Universidad del Zulia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03829800
    Brief Title
    Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in Type 2 Diabetes
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    November 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad del Zulia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Glycemic Index, Insulin, Incretins, Diabetes Mellitus type 2, Subjective appetite, Nutritional formula

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ensure® Abbott Nutrition
    Arm Type
    Experimental
    Arm Description
    A standard nutritional formula not specific for diabetics
    Arm Title
    Glucerna® Abbott Nutrition
    Arm Type
    Experimental
    Arm Description
    A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
    Arm Title
    Diasip® Nutricia Advanced
    Arm Type
    Experimental
    Arm Description
    A formula whose composition has isomaltulose and resistant starch
    Arm Title
    Glicolab®
    Arm Type
    Active Comparator
    Arm Description
    Glucose solution
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ensure® Abbott Nutrition
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Glucerna® Abbott Nutrition
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Diasip® Nutricia Advanced
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Glicolab®
    Intervention Description
    Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes
    Primary Outcome Measure Information:
    Title
    Change from baseline Glycemia at 180 minutes
    Description
    mmol/L
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Insulin at 180 minutes
    Description
    milliunits per liter (mU/L)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Glycemic Index (GI)
    Description
    Low GI (≤ 55), Intermediate (55-69) and High (≥70)
    Time Frame
    180 minutes after intake of each formula
    Title
    Glycemic Load (GL)
    Description
    High GL (> 20), Intermediate GL (11-19) and Low GL (<10)
    Time Frame
    180 minutes after intake of each formula
    Title
    Change from baseline GLP-1 at 180 minutes
    Description
    pmol/L
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline GIP at 180 minutes
    Description
    pg/mL
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Hunger at 180 minutes
    Description
    Visual Analogue Scale (mm)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Fullness at 180 minutes
    Description
    Visual Analogue Scale (mm)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Desire to eat at 180 minutes
    Description
    Visual Analogue Scale (mm)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Prospective food consumption at 180 minutes
    Description
    Visual Analogue Scale (mm)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Title
    Change from baseline Subjective appetite at 180 minutes
    Description
    Visual Analogue Scale (mm)
    Time Frame
    Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
    Secondary Outcome Measure Information:
    Title
    Age
    Description
    years
    Time Frame
    Baseline
    Title
    Weight
    Description
    kg
    Time Frame
    Baseline
    Title
    Height
    Description
    m
    Time Frame
    Baseline
    Title
    Body Mass Index
    Description
    kg/m^2
    Time Frame
    Baseline
    Title
    Hip Circumference
    Description
    cm
    Time Frame
    Baseline
    Title
    Total Cholesterol
    Description
    mg/dl
    Time Frame
    Baseline
    Title
    HDL-C
    Description
    mg/dl
    Time Frame
    Baseline
    Title
    LDL-C
    Description
    mg/dl
    Time Frame
    Baseline
    Title
    Triacylglycerides
    Description
    mg/dl
    Time Frame
    Baseline
    Title
    HbA1c
    Description
    percentage (%)
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    63 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisse Angarita, PhD
    Organizational Affiliation
    Universidad Andrés Bello, Facultad de Medicina - Sede Concepción
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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