Clinical trial NCT04105608: GLP-1 and Oxyntomodulin Release in Relation to Diet in Type 2 Diabetes Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-2 Diabetes
Keywords: Diabetes
GLP-1
Oxyntomodulin
Diet
Visual Analogue Scale
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in serum GLP-1 concentration
timeFrame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Secondary outcomes:
measure: Changes in plasma oxyntomodulin concentration
timeFrame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
measure: Serum glucose and insulin levels
timeFrame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
measure: Hunger-satiety scores (millimeters)
timeFrame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio-Medico University of Rome
Study officials:
References:
citation: 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.