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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Ensure® Abbott Nutrition
* Dietary Supplement: Glucerna® Abbott Nutrition
* Dietary Supplement: Diasip® Nutricia Advanced
* Dietary Supplement: Glicolab®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ensure® Abbott Nutrition<br>A standard nutritional formula not specific for diabetics | Dietary Supplement: Ensure® Abbott Nutrition<br>* 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<br>|
| Experimental: Glucerna® Abbott Nutrition<br>A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt | Dietary Supplement: Glucerna® Abbott Nutrition<br>* 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<br>|
| Experimental: Diasip® Nutricia Advanced<br>A formula whose composition has isomaltulose and resistant starch | Dietary Supplement: Diasip® Nutricia Advanced<br>* 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<br>|
| Active Comparator: Glicolab®<br>Glucose solution | Dietary Supplement: Glicolab®<br>* Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Glycemia at 180 minutes | mmol/L | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 
| Change from baseline Insulin at 180 minutes | milliunits per liter (mU/L) | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 
| Glycemic Index (GI) | Low GI (≤ 55), Intermediate (55-69) and High (≥70) | 180 minutes after intake of each formula | 
| Glycemic Load (GL) | 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 | pmol/L | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 
| Change from baseline GIP at 180 minutes | pg/mL | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 
| Change from baseline Hunger at 180 minutes | Visual Analogue Scale (mm) | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 
| Change from baseline Fullness at 180 minutes | 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 | 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 | 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 | Visual Analogue Scale (mm) | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, Insulin, Incretins, Diabetes Mellitus type 2, Subjective appetite, Nutritional formula