NCT02006459

Brief Summary

We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated glucose disposal. In order to do so we will perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

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

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 27, 2013

Last Update Submit

November 30, 2015

Conditions

Diabetes

Keywords

Gastrointestinal-mediated glucose disposalTotal pancreatectomyIncretin hormonesGlucagon

Outcome Measures

Primary Outcomes (2)

  • Gastrointestinal-mediated glucose disposal (GIGD)

    GIGD will be calculated based on the amounts of glucose utilised during the two glucose administrations forms, OGTT and IIGI (GIGD (%) = 100%×(glucoseOGTT-glucoseIIGI)/glucoseOGTT)

    Calculated when the study days are all complete. approximately in 6month

  • plasma Glucagon

    Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.

Secondary Outcomes (3)

  • endogenous glucose production

    Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.

  • Incretin Hormones

    incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.

  • Satiety, hunger, appetite

    Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180 min during each day.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated at/or cared for at the endocrinology out-patient-clinic, Rigshospitalet, University of Copenhagen, Copenhagen Denmark

You may qualify if:

  • Pancreatectomized patients
  • Caucasians above 18 years of age who have undergone total pancreatectomy
  • Normal haemoglobin
  • Informed consent Healthy Subjects
  • Normal fasting plasma glucose (FPG) and normal HbA1C (according to the World Health Organization (WHO) criteria)
  • Normal haemoglobin
  • Age above 18 years
  • Informed consent

You may not qualify if:

  • Pancreatectomized patients
  • Inflammatory bowel disease
  • Operation within the last 3 months
  • Ongoing chemotherapy or chemotherapy within the last 3 months
  • Ostomy
  • Nephropathy (serum creatinine \>150 µM and/or albuminuria)
  • Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>3×normal values)
  • Pregnancy and/or breastfeeding
  • Age above 80 years
  • Any condition that the investigator feels would interfere with trial participation Healthy Subjects
  • Diabetes mellitus (DM)
  • Prediabetes (impaired glucose tolerance and/or impaired FPG)
  • First degree relatives with DM
  • Inflammatory bowel disease
  • Intestinal resection and/or ostomy
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Division, University Hospital Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Lund A, Bagger JI, Wewer Albrechtsen NJ, Christensen M, Grondahl M, Hartmann B, Mathiesen ER, Hansen CP, Storkholm JH, van Hall G, Rehfeld JF, Hornburg D, Meissner F, Mann M, Larsen S, Holst JJ, Vilsboll T, Knop FK. Evidence of Extrapancreatic Glucagon Secretion in Man. Diabetes. 2016 Mar;65(3):585-97. doi: 10.2337/db15-1541. Epub 2015 Dec 15.

    PMID: 26672094DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum and buffycoat

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-student

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 10, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

DK(1)