Investigating the Incretin Effect in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT01975259
• Date of registration: 11/09/2013
• Prospective Registration: Yes
• Primary sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Public title: Investigating the Incretin Effect in Cystic Fibrosis IECF
• Scientific title: Investigating the Incretin Effect in Cystic Fibrosis
• Date of first enrolment: December 2013
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01975259
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Gareth H Jones, MBChB
• Affiliation: Liverpool Heart and Chest Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Cystic fibrosis as diagnosed by EITHER Cystic fibrosis transmembrane conductance
regulator (CFTR) mutation on genotyping OR Positive sweat test (Chloride =60mmol/L
after pilocarpine iontophoresis) AND Clinical features in keeping with a diagnosis of
Cystic Fibrosis

- Clinically stable for at least 4 weeks without inpatient or outpatient treatment for
an infective exacerbation - including antibiotics (other than long-term prophylactic
therapy) or steroids

Exclusion Criteria:

- Active Pregnancy or <12 months Post-partum

- Clinically unstable patients

- Patients on long-term steroids

- Patients with known gastroparesis or previous surgery to the gastrointestinal tract
(including vagotomy)

- History of organ transplant or planned organ transplant awaited

- Non-CF related diabetes (e.g. Type 1 or 2 Diabetes Mellitus)

- Active malignancy

- Clinically significant derangements in haematological or biochemical indices

- Clinical symptoms of malabsorption (frequent bowel motions/passing of
undigested foodstuffs or steatorrhoea)

- Known difficult venous access

- Use of bile acid sequestrants in the previous 4 weeks



Age minimum: 17 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Hyperglycemic clamp with placebo infusion

Other: Liquid Meal Test (Fat-rich)

Device: Continuous Glucose Monitoring

Other: Liquid Meal Test (Carbohydrate-rich)

Drug: Oral Glucose Tolerance test (75g 2-hour)

Other: Liquid Meal Test (Mixed)

Drug: Hyperglycemic clamp with concurrent GLP-1 infusion

Drug: Hyperglycemic Clamp with concurrent GIP infusion

Drug: Matched isoglycemic clamp

Drug: Modified Oral Glucose Tolerance Test (50g 4-hours)

Primary Outcome(s)

Volume of intravenous glucose required to maintain a hyperglycemic clamp at 180-216mg/dL [Time Frame: 3 hours]

Area Under Curve (AUC) of Insulin & C-peptide secretion during a matched isoglycemic clamp [Time Frame: 4 hours]

Secondary Outcome(s)

Serum DPP-4 levels [Time Frame: 0 mins]

AUC incretin hormone levels (GLP-1/GIP) [Time Frame: 4 hours]

Secondary ID(s)

2013-003758-26

1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors