NCT06068114

Brief Summary

This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated. For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Oct 2022Jun 2027

Study Start

First participant enrolled

October 5, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

4.7 years

First QC Date

September 26, 2023

Last Update Submit

May 16, 2024

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Functional DyspepsiaGastroparesisHealthy

Outcome Measures

Primary Outcomes (1)

  • Pyloric distensibility

    Pyloric distensibility measured by impedance planimetry (EndoFLIP device)

    At baseline and after 12 months

Secondary Outcomes (7)

  • GCSI score

    At baseline and after 6 and 12 months

  • PAGI-SYM score

    At baseline and after 6 and 12 months

  • PAGI-QoL score

    At baseline and after 6 and 12 months

  • Gastric emptying by scintigraphy

    At baseline and after 12 months

  • Gastric emptying by breath test

    At baseline and after 12 months

  • +2 more secondary outcomes

Study Arms (2)

Diabetic patients

Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis

Healthy controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients treated in any of the participating centers.

You may qualify if:

  • Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years

You may not qualify if:

  • Diabetes mellitus type II being treated with a diet only
  • Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization
  • Concomitant treatment with more than one prokinetic agent
  • Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
  • Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)
  • Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
  • Severe coagulopathy
  • Esophageal or gastric varices and /or portal gastropathy
  • Advanced liver cirrhosis
  • Pregnancy or puerperium
  • Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
  • The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed.
  • Systemic connective tissue disorder
  • Inability to obtain informed consent
  • Any other condition, which in the opinion of the investigator would interfere with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Nemocnice AGEL Ostrava-Vítkovice a. s.

Ostrava, 703 00, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, 708 52, Czechia

RECRUITING

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

RECRUITING

Military University Hospital Prague

Prague, 16902, Czechia

RECRUITING

University Hospital Trnava

Trnava, 917 02, Slovakia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Gastroparesis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eva Evinová, MD

CONTACT

eva.evinova@vtn.agel.cz

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Jan Martínek, MD, PhD, AGAF

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 5, 2023

Study Start

October 5, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

SL(1)CZ(4)