NCT04064203

Brief Summary

The overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

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

July 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

August 16, 2019

Last Update Submit

August 19, 2019

Conditions

Diabetes After Total Pancreatectomy

Keywords

glucagon

Outcome Measures

Primary Outcomes (1)

  • p-glucagon

    Plasma glucagon excursions measured as incremental area under the curve (iAUC)

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

Secondary Outcomes (5)

  • p-glucose

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

  • GIP, GLP-1, GLP-2, GIP, oxyntomodulin, ghrelin, peptide YY, gastrin

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

  • catecholamines

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

  • cortisol

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

  • growth hormone

    -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

Study Arms (2)

Totally pancreatectomized patients

EXPERIMENTAL

Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test

Other: Oral glucose tolerance testOther: Clamp experiment

Healthy controls

EXPERIMENTAL

Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test

Other: Oral glucose tolerance testOther: Clamp experiment

Interventions

Oral glucose tolerance testOTHER

50 grams OGTT

Healthy controlsTotally pancreatectomized patients
Clamp experimentOTHER

insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT

Healthy controlsTotally pancreatectomized patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatectomised patients
  • Caucasian above 30 years of age who have undergone total pancreatectomy
  • Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females Non-diabetic control subjects
  • Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria)
  • Normal blood haemoglobin
  • Caucasian above 30 years of age
  • BMI (body mass index) 17-30
  • Informed consent

You may not qualify if:

  • Pancreatectomised patients
  • Pancreatectomy within the last 3 months
  • Ongoing chemotherapy or chemotherapy within the last 3 months
  • Previous or ongoing treatment with GLP-1 receptor agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors
  • Inflammatory bowel disease
  • Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy
  • Nephropathy (eGFR\<60 and/or albuminuria)
  • Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>3 Ă— normal values)
  • Severe lung disease
  • Pregnancy and/or breastfeeding
  • Age above 85 years
  • Uncontrolled hypertension and/or significant cardiovascular disease
  • Any condition that the investigator feels would interfere with trial participation Non-diabetic control subjects
  • Diabetes or prediabetes (according to WHO criteria)
  • First-degree relatives with diabetes
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, Capital Region, 2900, Denmark

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 12 totally pancreatectomized patients and 12 healthy control subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant endocrinologist, Professor of

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 21, 2019

Study Start

July 5, 2017

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

DK(1)