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The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of GIP

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ClinicalTrials.gov Identifier: NCT02673554
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date February 4, 2016
Study Start Date  ICMJE May 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Insulin secretory response after GIP bolus or infusion. [ Time Frame: 210 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of GIP
Official Title  ICMJE The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of Glucose-dependent Insulinotropic Polypeptide (GIP) in Patients With Type 2 Diabetes is Not Caused by Rapid Tachyphylaxis
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. Oral glucose challenge;
  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. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180 min).

To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives, and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90 min apart, and compared this to a continued intravenous infusion of GIP.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: GIP Bolus
    bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp
  • Drug: GIP Clamp
    hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min
  • Procedure: Oral glucose tolerance test (OGTT)
    an oral glucose challenge (75 g)
  • Procedure: hyperglycemic clamp
    a hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l)
Study Arms  ICMJE
  • Experimental: Oral glucose tolerance test
    An oral glucose challenge (75 g)
    Intervention: Procedure: Oral glucose tolerance test (OGTT)
  • Active Comparator: GIP Bolus
    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
    Interventions:
    • Drug: GIP Bolus
    • Procedure: hyperglycemic clamp
  • Active Comparator: GIP Infusion
    Hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min
    Interventions:
    • Drug: GIP Clamp
    • Procedure: hyperglycemic clamp
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Exclusion of pregnancy
  • Exclusion of impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects
  • 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

Exclusion Criteria:

  • 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
  • Liver function limitations
  • Renal impairment ( serum creatinine > 1.5 mg/dl )
  • Alcohol or drug abuse
  • Participation in clinical trials in the last 3 months
  • Inability or unwillingness to comply with the requirements of the Protocol
  • Known hypersensitivity to GIP
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02673554
Other Study ID Numbers  ICMJE GIP and Tachyphylaxis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
Study Sponsor  ICMJE Diabeteszentrum Bad Lauterberg im Harz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael A. Nauck, Prof. Diabeteszentrum Bad Lauterberg
PRS Account Diabeteszentrum Bad Lauterberg im Harz
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP