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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Ensure® Abbott Nutrition; Dietary supplement: Glucerna® Abbott Nutrition; Dietary supplement: Diasip® Nutricia Advanced; Dietary supplement: Glicolab®

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 63 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad del Zulia
• Investigators: Principal Investigator: Lisse Angarita, PhD, Universidad Andrés Bello, Facultad de Medicina - Sede Concepción

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Insulin; Diabetes Mellitus type 2; Glycemic Index; Incretins; Nutritional formula; Subjective appetite
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1001092016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No