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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

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: GIP Bolus Drug: GIP Clamp Procedure: Oral glucose tolerance test (OGTT) Procedure: hyperglycemic clamp Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2004
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral glucose tolerance test
An oral glucose challenge (75 g)
Procedure: Oral glucose tolerance test (OGTT)
an oral glucose challenge (75 g)

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

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

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




Primary Outcome Measures :
  1. Insulin secretory response after GIP bolus or infusion. [ Time Frame: 210 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673554


Sponsors and Collaborators
Diabeteszentrum Bad Lauterberg im Harz
Investigators
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Principal Investigator: Michael A. Nauck, Prof. Diabeteszentrum Bad Lauterberg
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Responsible Party: Michael A. Nauck, Prof. Dr. med. Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
ClinicalTrials.gov Identifier: NCT02673554    
Other Study ID Numbers: GIP and Tachyphylaxis
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz:
Glucose-dependent Insulinotropic Polypeptide (GIP)
Glucagon-Like Peptide 1 (GLP-1)
Incretin
Insulin secretion
Tachyphylaxis
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases