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

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
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
NCT ID
NCT03829800
First Posted
January 28, 2019
Last Updated
February 1, 2019
Sponsor
Universidad del Zulia
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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