NCT02673554

Brief Summary

In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus bolus administration. The design was a two-way crossover design comparing repeated bolus injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such patients, and healthy subjects. Investigators performed a:

  1. 1.Oral glucose challenge;
  2. 2.hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg body weight at 30 and 120 min); and
  3. 3.hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180 min).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

January 28, 2016

Last Update Submit

February 1, 2016

Conditions

Type 2 Diabetes

Keywords

Glucose-dependent Insulinotropic Polypeptide (GIP)Glucagon-Like Peptide 1 (GLP-1)IncretinInsulin secretionTachyphylaxis

Outcome Measures

Primary Outcomes (1)

  • Insulin secretory response after GIP bolus or infusion.

    210 minutes

Study Arms (3)

Oral glucose tolerance test

EXPERIMENTAL

An oral glucose challenge (75 g)

Procedure: Oral glucose tolerance test (OGTT)

GIP Bolus

ACTIVE COMPARATOR

Hyperglycemic clamp (capillary venous glucose concentration \~ 8.5 mmol/l) with two repeated intravenous bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp

Drug: GIP BolusProcedure: hyperglycemic clamp

GIP Infusion

ACTIVE COMPARATOR

Hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min

Drug: GIP ClampProcedure: hyperglycemic clamp

Interventions

GIP BolusDRUG

bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp

GIP Bolus
GIP ClampDRUG

hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min

GIP Infusion
Oral glucose tolerance test (OGTT)PROCEDURE

an oral glucose challenge (75 g)

Oral glucose tolerance test
hyperglycemic clampPROCEDURE

a hyperglycemic clamp (capillary venous glucose concentration \~ 8.5 mmol/l)

GIP BolusGIP Infusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current diagnosis of type 2 diabetes according to the guidelines of the German Diabetes Association (DDG) ( Kerner et al . 2001) in subjects of diabetes group
  • fasting glucose ≤ 150 mg/dl
  • Body-mass-index ≥ 20 kg/m²
  • Written consent

You may not qualify if:

  • Type 1 diabetes
  • Impaired glucose tolerance or Type 2 diabetes in metabolical healthy subjects
  • Ketone bodies urine diagnostics at least ++
  • Acidosis
  • Fasting blood glucose \> 150 mg/dl
  • Body-mass-index \< 20 kg/m²
  • No written consent
  • Pregnancy or unsafe contraception in women before menopause
  • Active malignancy
  • Angina as current, unsolved clinical problem
  • Inadequately treated or untreated arterial hypertension ( \> 160 mmHg systolic and / or \> 95 mmHg diastolic )
  • Infection / fever \> 37.5 ° C
  • Treatment with glucocorticoids
  • Insulin therapy within the last three months
  • Anemia with a hemoglobin level \< 12 g/dl
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael A. Nauck, Prof.

    Diabeteszentrum Bad Lauterberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Michael A. Nauck

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 4, 2016

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share