NCT00713440

Brief Summary

The purpose of this study is to evaluate whether the reduced incretin effect and the paradoxical glucagon responses during oral glucose ingestion and isoglycaemic iv glucose infusion observed in patients with type 2 diabetes are causes (non-inducible in lean healthy subjects without family history of diabetes) or consequences (inducible) of the diabetic state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

July 7, 2008

Last Update Submit

August 5, 2009

Conditions

Type 2 Diabetes MellitusSteroids

Keywords

Incretin EffectSteroidsGlucagon-Like Peptide 1Gastric Inhibitory PeptideGlucose-dependent Insulinotropic PolypeptideInsulinC-peptideGlucagon

Outcome Measures

Primary Outcomes (1)

  • Incretin effect before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids.

    One year

Secondary Outcomes (1)

  • GLP-1 and GIP response curves

    One year

Study Arms (1)

1

EXPERIMENTAL

10 healthy Caucasian subjects without family history of diabetes

Other: Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol

Interventions

Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; ParacetamolOTHER

OGTT: The test is performed with 50 g of glucose deluded in 300 ml. of water. Isoglycaemic iv. clamp: Iv glucose infusion mimicking the glucose response curve of the OGTT. Liquid Meal Test: The test is performed with 100g of formula milk in 300 ml. of water. Gastric Emptying Rate: Paracetamol absorption test. Adrenocortical Steroids: Use of 37,5 mg./day of prednisolone during 10 days

Also known as: Prednisolone, Paracetamol
1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasians without Type 2 or Type 1 Diabetes
  • Normal OGTT (75 g of glucose) according to WHO criteria
  • Normal hemoglobin
  • Normal blood pressure

You may not qualify if:

  • Liver disease
  • Kidney disease
  • Relatives (parents/siblings) with type 2 diabetes
  • Pregnancy
  • Contra-indications to treatment with adrenocortical steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Physiology Department; Glostrup Univesity Hospital

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (1)

  • Hansen KB, Vilsboll T, Bagger JI, Holst JJ, Knop FK. Increased postprandial GIP and glucagon responses, but unaltered GLP-1 response after intervention with steroid hormone, relative physical inactivity, and high-calorie diet in healthy subjects. J Clin Endocrinol Metab. 2011 Feb;96(2):447-53. doi: 10.1210/jc.2010-1605. Epub 2010 Nov 3.

    PMID: 21047927DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Glucose Tolerance TestPrednisoloneAcetaminophen

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Filip K Knop, MD; Ph-D

    Gentofte University Hospital

    STUDY DIRECTOR

  • Tina Vilsboll, MD; Ph-D, DMSc

    University of Copenhagen

    STUDY CHAIR

  • Katrine B Hansen, MD

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

  • Steen Larsen, MD; DMSc

    Glostrup University Hospital

    STUDY CHAIR

  • Jens J Holst, Professor: DMSc

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

DK(1)