NCT03644199

Brief Summary

This is a crossover study to determine the possible factors that might be related to the development of diabetes in CF and examines the relationship between pancreatic fatigue if any, and the development of diabetes. In addition hormones affecting the release of insulin and stomach motility will be studied to determine if there is a variation in response to solid and liquid meals and if this variation increases as fatigue progresses.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

May 10, 2016

Last Update Submit

August 21, 2018

Conditions

Cystic Fibrosis

Keywords

Gastric emptyingCystic Fibrosis related diabetesIncretins

Outcome Measures

Primary Outcomes (1)

  • Glucose levels

    Glucose sensitivity test

    4 hours

Secondary Outcomes (3)

  • Insulin responses

    4 hours

  • GLP1 and GIP responses

    4 hours

  • Evaluation of gastric emptying

    8 hours

Study Arms (2)

OGTT test

OTHER

Comparison of responses to a OGTT between CF subjects and health control subjects

Other: Oral Glucose Tolerance Test (OGTT) assessment arm

Mixed meal

OTHER

Comparison of responses to a mixed meal through the day between CF subjects and health control subjects

Other: Mixed meal test evaluation test arm

Interventions

Oral Glucose Tolerance Test (OGTT) assessment armOTHER

Hormonal and motility responses to a standard OGTT evaluation arm

OGTT test
Mixed meal test evaluation test armOTHER

Evaluate the hormonal and motility responses to a standard mixed meal test through the day

Mixed meal

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female with a confirmed diagnosis of cystic fibrosis defined by
  • Clinical features consistent with a diagnosis of CF AND
  • Sweat chloride ≥60mmol/L by pilocarpine ionotophoresis; OR
  • Genotypic confirmation of CFTR mutation
  • Aged 18 - 50 years
  • Out-patients from the regional adult unit in Liverpool
  • Currently not known to be diabetic or on insulin
  • Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
  • Hemoglobin value \>10g/dl
  • Male or female with NO confirmed diagnosis of cystic fibrosis
  • Aged 18 - 50 years
  • Currently not known to be diabetic or on insulin
  • Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
  • Hemoglobin value \>10g/dl

You may not qualify if:

  • Patients with known diabetes or on glucose lowering medications (insulin, oral agents)
  • On-going acute illness
  • Those on long-term oral steroids
  • Pregnant women
  • Those on immunosuppressive treatment
  • History of, or planned organ transplant
  • Clinically significant abnormal findings on haematology or clinical chemistry
  • Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator.
  • Current malignant disease
  • Any serious or active medical or psychiatric illness, which in eth opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Dilip Nazareth, MD

    Liverpool Heart & Chest Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

August 23, 2018

Study Start

March 30, 2011

Primary Completion

July 30, 2013

Study Completion

August 30, 2017

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

GB(1)