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

NCT ID: NCT04105608

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-02-28

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.

Conditions

Type-2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFV meal

A vegetarian meal high in dietary carbohydrate and fiber

Group Type: EXPERIMENTAL

High-fiber vegetarian meal

Intervention Type: DIETARY_SUPPLEMENT

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

MED meal

A Mediterranean-like meal

Group Type: ACTIVE_COMPARATOR

Mediterranean-like meal

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

High-fiber vegetarian meal

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

Intervention Type: DIETARY_SUPPLEMENT

Mediterranean-like meal

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Control 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonio Di Mauro

OTHER

Sponsor Role: lead

Responsible Party

Antonio Di Mauro

Registered Dietitian Nutritionist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Campus Bio-Medico University of Rome

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32926502 (View on PubMed)

Other Identifiers

08/2017

Identifier Type: -

Identifier Source: org_study_id