Clinical trial NCT03829800: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Glycemic Index
Insulin
Incretins
Diabetes Mellitus type 2
Subjective appetite
Nutritional formula
Lead sponsor: Universidad del Zulia
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 23
Sex: ALL
Minimum age (years): 51
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Change from baseline Glycemia at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Insulin at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Glycemic Index (GI)
timeFrame: 180 minutes after intake of each formula
measure: Glycemic Load (GL)
timeFrame: 180 minutes after intake of each formula
measure: Change from baseline GLP-1 at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline GIP at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Hunger at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Fullness at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Desire to eat at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Prospective food consumption at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
measure: Change from baseline Subjective appetite at 180 minutes
timeFrame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Hip Circumference
timeFrame: Baseline
measure: Total Cholesterol
timeFrame: Baseline
measure: HDL-C
timeFrame: Baseline
measure: LDL-C
timeFrame: Baseline
measure: Triacylglycerides
timeFrame: Baseline
measure: HbA1c
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Andrés Bello, Facultad de Medicina - Sede Concepción
name: Lisse Angarita, PhD
role: PRINCIPAL_INVESTIGATOR
References: