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GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes (GIP-HYPO-T2DM)

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ClinicalTrials.gov Identifier: NCT01414556
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : April 2, 2013
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen

Brief Summary:
Investigation of GIP effects at fasting and hypoglycemia

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Glucose-dependent Insulinotropic polypeptide Other: saline Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: hyperglycemia Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Other: saline
Experimental: fasting glycemia Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Other: saline
Experimental: hypoglycemia Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Other: saline



Primary Outcome Measures :
  1. glucagon/insulin(c-peptide) absolute, incremental and area under curve values [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]

Secondary Outcome Measures :
  1. plasma gut hormones and nutrients [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

  • HbA1c >9 %
  • Liver disease (ALAT/ASAT >2 x upper normal limit)
  • Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
  • Proliferative diabetic retinopathy (anamnestic)
  • Severe arteriosclerosis or heart failure (NYHA group III og IV)
  • Anemia
  • treatment with medication not applicable to pause for 12 hours
  • Fasting plasma glucose >15 mM on screening day.

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): NCT01414556


Locations
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Mikkel Christensen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mikkel Christensen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01414556     History of Changes
Other Study ID Numbers: H-2-2009-078
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
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