NCT00803296

Brief Summary

The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Last Updated

January 13, 2010

Status Verified

December 1, 2008

Enrollment Period

2 years

First QC Date

December 4, 2008

Last Update Submit

January 12, 2010

Conditions

Incretin EffectInsulin ResistanceType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Incretin effect

    2 days

Secondary Outcomes (1)

  • Insulin resistance

    2 days

Study Arms (4)

Obese patients with type 2 diabetes

Patients with type 2 diabetes and BMI\>33

Other: Oral glucose tolerance test (OGTT)Other: Isoglycemic intravenous glucose infusion

Obese subjects with normal glucose tolerance

Subjects with normal glucose tolerance and BMI\>33

Other: Oral glucose tolerance test (OGTT)Other: Isoglycemic intravenous glucose infusion

Lean subjects with type 2 diabetes

Patients with type 2 diabetes and BM\<25

Other: Oral glucose tolerance test (OGTT)Other: Isoglycemic intravenous glucose infusion

Lean subjects with normal glucose tolerance

Subjects with normal glucose tolerance and BM\<25

Other: Oral glucose tolerance test (OGTT)Other: Isoglycemic intravenous glucose infusion

Interventions

Oral glucose tolerance test (OGTT)OTHER
Lean subjects with normal glucose toleranceLean subjects with type 2 diabetesObese patients with type 2 diabetesObese subjects with normal glucose tolerance
Isoglycemic intravenous glucose infusionOTHER
Lean subjects with normal glucose toleranceLean subjects with type 2 diabetesObese patients with type 2 diabetesObese subjects with normal glucose tolerance

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lean and obese patients with type 2 diabetes; and matched healthy control subjects.

You may qualify if:

  • Diagnosed with type 2 diabetes for at least 3 months
  • Normal blood hemoglobin
  • Informed consent

You may not qualify if:

  • Liver disease
  • Diabetic nephropathy
  • Treatment with medication that can not be stopped for 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital, University of Copenhagen

Hellerup, Copenhagen, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tina Vilsbøll, MD DMSc

    Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

June 1, 2008

Last Updated

January 13, 2010

Record last verified: 2008-12

Locations

DK(1)