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Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

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ClinicalTrials.gov Identifier: NCT01048268
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen

Brief Summary:
The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: glucose-dependent insulinotropic polypeptide Drug: Placebo Phase 1 Phase 2

Detailed Description:

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, we will evaluate GIP's role as blood sugar stabilizer.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
Study Start Date : December 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Healthy volunteers Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight


Drug: Placebo
copy GIP infusion rates

Experimental: Patients with Type 1 diabetes mellitus Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight


Drug: Placebo
copy GIP infusion rates

Experimental: Patients with type 2 diabetes mellitus Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight


Drug: Placebo
copy GIP infusion rates




Primary Outcome Measures :
  1. The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon [ Time Frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit ]

Secondary Outcome Measures :
  1. The difference between the amount of infused glucose and the insulin responses [ Time Frame: will be measured at each visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
  • Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
  • Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
  • Normal hemoglobin
  • Informed consent

Exclusion criteria:

  • Unwillingness to participate or the wish to leave the present study
  • HbA1c > 9 %
  • Liver disease (ALAT or ASAT > 2 times normal value)
  • Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
  • Proliferative diabetic retinopathy (anamnetic)
  • Atherosclerotic heart disease or heart failure (NYHA group III and IV)
  • Anemia
  • Treatment with medicine which cannot be paused for 12 hours
  • Pregnancy and/or breast feeding
  • Fasting plasma glucose > 15 mM on the day of the experiment

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): NCT01048268


Locations
Denmark
Department of Internal Medicine F' laboratory
Hellerup, Copenhagen County, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Mikkel Christensen, MD Bispebjerg Hospital, Copenhagen
Study Director: Filip K Knop, MD PhD Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen

Responsible Party: Mikkel Christensen, MD, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01048268     History of Changes
Other Study ID Numbers: GIP HYPO (MC)
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by Mikkel Christensen, University Hospital, Gentofte, Copenhagen:
T1DM
T2DM
GIP
Glucose-dependent insulinotropic polypeptide
Incretin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs