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

NCT03829800 | Completed DMC

• 1 other identifier: 1001092016
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Glycemic Index; Insulin; Incretins; Diabetes Mellitus type 2; Subjective appetite; Nutritional formula

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Age

  Baseline

• Weight

  Baseline

• Height

  Baseline

• Body Mass Index

  Baseline

• Hip Circumference

  Baseline

Study Arms (4)

Ensure® Abbott Nutrition

EXPERIMENTAL

A standard nutritional formula not specific for diabetics

Dietary Supplement: Ensure® Abbott Nutrition

Glucerna® Abbott Nutrition

EXPERIMENTAL

A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt

Dietary Supplement: Glucerna® Abbott Nutrition

Diasip® Nutricia Advanced

EXPERIMENTAL

A formula whose composition has isomaltulose and resistant starch

Dietary Supplement: Diasip® Nutricia Advanced

Glicolab®

ACTIVE COMPARATOR

Glucose solution

Dietary Supplement: Glicolab®

Interventions

Ensure® Abbott Nutrition DIETARY_SUPPLEMENT

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

Ensure® Abbott Nutrition

Glucerna® Abbott Nutrition DIETARY_SUPPLEMENT

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

Glucerna® Abbott Nutrition

Diasip® Nutricia Advanced DIETARY_SUPPLEMENT

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

Diasip® Nutricia Advanced

Glicolab® DIETARY_SUPPLEMENT

Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes

Glicolab®

Eligibility Criteria

• Age: 51 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad del Zulia: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Lisse Angarita, PhD

  Universidad Andrés Bello, Facultad de Medicina - Sede Concepción

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 15, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share