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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01414556
First received: August 5, 2011
Last updated: March 31, 2013
Last verified: March 2013
  Purpose

Investigation of GIP effects at fasting and hypoglycemia


Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: Glucose-dependent Insulinotropic polypeptide
Other: saline
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • glucagon/insulin(c-peptide) absolute, incremental and area under curve values [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma gut hormones and nutrients [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414556

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

No publications provided by University Hospital, Gentofte, Copenhagen

Additional 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
Study First Received: August 5, 2011
Last Updated: March 31, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014