Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT00944593
Eligibility Criteria:
Inclusion criteria: • Type 1 diabetes mellitus, confirmed by history of persistent insulin treatment from 12 months' or less after diagnosis, and fasting C peptide concentration of \<0.16nmol/L.74
* At least moderate symptoms of gastroenteropathy (GCSI \>27)
* Delayed gastric emptying on breath test performed at screening (if no results available)
Disease control
* Type 1 diabetes mellitus, confirmed by history of persistent insulin treatment from 12 months' or less after diagnosis, and fasting C peptide concentration of \<0.16nmol/L.74
* Not more than mild symptoms of gastroenteropathy / dyspepsia (GCSI \<14).
* Normal gastric emptying on breath test performed at screening (if no results available)
Normal control
* Healthy volunteers recruited by advertisement.
* Not more than mild symptoms of gastroenteropathy / dyspepsia (GCSI \<14).
* Normal gastric emptying on breath test performed at screening (if no results available)
General inclusion criteria
* Aged at least 18 and not more than 55 years.
* Body Mass Index: 19-27 kg/m2
* Ability to communicate with the investigator and comply with requirements for entire study.
* Ability to provide written, informed consent
Exclusion criteria: General exclusion criteria
* Gross retention of gastric contents (e.g. bezoar) or evidence of peptic ulcer disease or significant pathology (other than reflux oesophagitis) on upper gastrointestinal endoscopy
* History of gastro-intestinal surgery (except appendicectomy and hernia repair).
* History of abdominal radiotherapy or malignancy
* Mental impairment or psychological disease limiting ability to comply with study requirements
* Progressive or unstable co-morbid condition requiring treatment or precluding safe endoscopic placement of naso-jejunal feeding tube.
* Patients at risk of pregnancy without effective contraception
* Evidence or history of drug or alcohol abuse within two years.
* Unable or unwilling to stop medications influencing upper GI motility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00944593
Study Brief:
Protocol Section:
NCT00944593