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Completed

NCT Number: NCT03829800

Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in 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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

51 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

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

Glicolab®

Dietary Supplement

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

Primary outcomes

  1. Change from baseline Glycemia at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    mmol/L

  2. Change from baseline Insulin at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    milliunits per liter (mU/L)

  3. Glycemic Index (GI)

    Time frame: 180 minutes after intake of each formula

    Low GI (≤ 55), Intermediate (55-69) and High (≥70)

  4. Glycemic Load (GL)

    Time frame: 180 minutes after intake of each formula

    High GL (> 20), Intermediate GL (11-19) and Low GL (<10)

  5. Change from baseline GLP-1 at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    pmol/L

  6. Change from baseline GIP at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    pg/mL

  7. Change from baseline Hunger at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    Visual Analogue Scale (mm)

  8. Change from baseline Fullness at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    Visual Analogue Scale (mm)

  9. Change from baseline Desire to eat at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    Visual Analogue Scale (mm)

  10. Change from baseline Prospective food consumption at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    Visual Analogue Scale (mm)

  11. Change from baseline Subjective appetite at 180 minutes

    Time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.

    Visual Analogue Scale (mm)

Secondary outcomes

  1. Age

    Time frame: Baseline

    years

  2. Weight

    Time frame: Baseline

    kg

  3. Height

    Time frame: Baseline

    m

  4. Body Mass Index

    Time frame: Baseline

    kg/m^2

  5. Hip Circumference

    Time frame: Baseline

    cm

  6. Total Cholesterol

    Time frame: Baseline

    mg/dl

  7. HDL-C

    Time frame: Baseline

    mg/dl

  8. LDL-C

    Time frame: Baseline

    mg/dl

  9. Triacylglycerides

    Time frame: Baseline

    mg/dl

  10. HbA1c

    Time frame: Baseline

    percentage (%)

Sponsors and collaborators

Lead sponsor

Universidad del Zulia

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 4, 2019
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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