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VAS

CompletedPhase NA

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

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.

Lead sponsor

Antonio Di Mauro

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

12

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

BMI 25-35

Primary endpoint

Plasma concentration (steady state)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04105608
Org study ID08/2017

Timeline

Milestones

Study start2017-11-01actual
Primary completion2017-12-01actual
Study completion2018-02-28actual
Study first posted2019-09-26actual
Last update posted2019-09-26actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Serum glucose and insulin levels

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

Postprandial glucose

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Hunger-satiety scores (millimeters)

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

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Changes in serum GLP-1 concentration

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

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Changes in plasma oxyntomodulin concentration

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

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.