Diabetes Mellitus, Type 2
Conditions
Keywords
Glycemic Index, Insulin, Incretins, Diabetes Mellitus type 2, Subjective appetite, Nutritional formula
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.
Interventions
DIETARY_SUPPLEMENTEnsure® 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
DIETARY_SUPPLEMENTGlucerna® 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
DIETARY_SUPPLEMENTDiasip® 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
DIETARY_SUPPLEMENTGlicolab®
Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes
Sponsors
Universidad del Zulia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
Eligibility
Sex/Gender
ALL
Age
51 Years to 63 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Subjective appetite at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | Visual Analogue Scale (mm) |
| Change from baseline Glycemia at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | mmol/L |
| Change from baseline Insulin at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | milliunits per liter (mU/L) |
| Glycemic Index (GI) | 180 minutes after intake of each formula | Low GI (≤ 55), Intermediate (55-69) and High (≥70) |
| Glycemic Load (GL) | 180 minutes after intake of each formula | High GL (\> 20), Intermediate GL (11-19) and Low GL (\<10) |
| Change from baseline GLP-1 at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | pmol/L |
| Change from baseline GIP at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | pg/mL |
| Change from baseline Hunger at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | Visual Analogue Scale (mm) |
| Change from baseline Fullness at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | Visual Analogue Scale (mm) |
| Change from baseline Desire to eat at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | Visual Analogue Scale (mm) |
| Change from baseline Prospective food consumption at 180 minutes | Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180. | Visual Analogue Scale (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline | kg |
| Height | Baseline | m |
| Body Mass Index | Baseline | kg/m\^2 |
| Hip Circumference | Baseline | cm |
| Total Cholesterol | Baseline | mg/dl |
| HDL-C | Baseline | mg/dl |
| LDL-C | Baseline | mg/dl |
| Triacylglycerides | Baseline | mg/dl |
| HbA1c | Baseline | percentage (%) |
| Age | Baseline | years |
Outcome results
None listed