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Completed

NCT Number: NCT04105608

GLP-1 and Oxyntomodulin Release in Relation to Diet in Type 2 Diabetes Patients.

The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.

Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.

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Key information

Conditions

Type-2 Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio-Medico University of Rome

Rome, 00128, Italy

About this study

Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.

The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.

Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.

Exclusion criteria

  • clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.

Treatment and study plan

High-fiber vegetarian meal

Dietary Supplement

The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.

Mediterranean-like meal

Dietary Supplement

The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.

Other names: Control meal

Primary outcomes

  1. Changes in serum GLP-1 concentration

    Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

    Changes in serum GLP-1 levels following the ingestion of the two meals

Secondary outcomes

  1. Changes in plasma oxyntomodulin concentration

    Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

    Plasma oxyntomodulin assessment in relation to HFV and MED meal.

  2. Serum glucose and insulin levels

    Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

    Serum blood glucose and insulin levels

  3. Hunger-satiety scores (millimeters)

    Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

    We assessed VAS scores in relation to meals through the quantification of self-reported hunger, satiety, and desire to eat. Participants were asked to mark a validated 10-mm horizontal scale (Visual analogue scale) at multiple time points [0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)]. These ratings were subsequently quantified and assessed for potential correlation with any of the hormones assessed (i.e., GLP-1, oxyntomodulin, glucose, and insulin). Each scale had a left end equal to zero mm (i.e., "not at all") and a right end equal to 100 mm (i.e., "absolutely" or "definitely yes"), with no subscales. Each participant was instructed on how to fill the questionnaire properly and every assessment occurred with no disturbance and/or any other patient.

Sponsors and collaborators

Lead sponsor

Antonio Di Mauro

Other

Registry information

Official study title

A Mediterranean-pattern Meal Increases GLP-1 and Oxyntomodulin More Than an Energy-matched High Fiber Plant-Based Meal in Type 2 Diabetes Patients: A Randomized Clinical Trial Assessment Through the Visual Analogue Scale.

Acronym: VAS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2019
Registry last updated
Sep 26, 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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