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

Type-2 Diabetes Clinical Trial

— VAS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105608
• Other study ID #: 08/2017
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: September 2019
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type-2 Diabetes

Intervention

Dietary Supplement:
• High-fiber vegetarian meal
The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.
• Mediterranean-like meal
The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.

Locations

Country	Name	City	State
Italy	Campus Bio-Medico University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Antonio Di Mauro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Serum glucose and insulin levels	Serum blood glucose and insulin levels	0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Secondary	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)