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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829800
• Other study ID #: 1001092016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: November 15, 2018

Study information

• Verified date: February 2019
• Source: Universidad del Zulia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 15, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 63 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Ensure® 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
• Glucerna® 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
• Diasip® 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
• Glicolab®
Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Zulia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Glycemia at 180 minutes	mmol/L	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Primary	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.
Primary	Glycemic Index (GI)	Low GI (= 55), Intermediate (55-69) and High (=70)	180 minutes after intake of each formula
Primary	Glycemic Load (GL)	High GL (> 20), Intermediate GL (11-19) and Low GL (<10)	180 minutes after intake of each formula
Primary	Change from baseline GLP-1 at 180 minutes	pmol/L	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Primary	Change from baseline GIP at 180 minutes	pg/mL	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Primary	Change from baseline Hunger at 180 minutes	Visual Analogue Scale (mm)	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Primary	Change from baseline Fullness at 180 minutes	Visual Analogue Scale (mm)	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Primary	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.
Primary	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.
Primary	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	Age	years	Baseline
Secondary	Weight	kg	Baseline
Secondary	Height	m	Baseline
Secondary	Body Mass Index	kg/m^2	Baseline
Secondary	Hip Circumference	cm	Baseline
Secondary	Total Cholesterol	mg/dl	Baseline
Secondary	HDL-C	mg/dl	Baseline
Secondary	LDL-C	mg/dl	Baseline
Secondary	Triacylglycerides	mg/dl	Baseline
Secondary	HbA1c	percentage (%)	Baseline