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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type-2 Diabetes
• Intervention / Treatment: Dietary supplement: High-fiber vegetarian meal; Dietary supplement: Mediterranean-like meal

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00128
    • Campus Bio-Medico University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFV meal; A vegetarian meal high in dietary carbohydrate and fiber	Dietary supplement: High-fiber vegetarian meal; The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.
Active Comparator: MED meal; A Mediterranean-like meal	Dietary supplement: Mediterranean-like meal; The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.; Other Names: Control meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in serum GLP-1 concentration	Changes in serum GLP-1 levels following the ingestion of the two meals	0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in plasma oxyntomodulin concentration	Plasma oxyntomodulin assessment in relation to HFV and MED meal.	0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Serum glucose and insulin levels	Serum blood glucose and insulin levels	0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Hunger-satiety scores (millimeters)	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.	0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

Collaborators and Investigators

• Sponsor: Antonio Di Mauro

Publications and helpful links

General Publications

• Di Mauro A, Tuccinardi D, Watanabe M, Del Toro R, Monte L, Giorgino R, Rampa L, Rossini G, Kyanvash S, Soare A, Rosati M, Piccoli A, Napoli N, Fioriti E, Pozzilli P, Khazrai YM, Manfrini S. The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial. Diabetes Metab Res Rev. 2021 Sep;37(6):e3406. doi: 10.1002/dmrr.3406. Epub 2020 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; GLP-1; Diet; Visual Analogue Scale; Oxyntomodulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 08/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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