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Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00704795
First received: June 24, 2008
Last updated: June 25, 2008
Last verified: June 2008
History of Changes
  Purpose

In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.


Condition Intervention
Hyperglucagonemia
Hyperglycemia
Diabetes Mellitus
 Other: Oral glucose tolerance test
Other: Isoglycemic iv glucose infusion

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively. [ Time Frame: months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responses of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) as assessed by AUC during 50-g OGTT and isoglycemic iv glucose infusion, respectively. [ Time Frame: months ] [ Designated as safety issue: No ]
  • GI-mediated glucose tolerance as assessed by the amount of glucose ingested as compared to the amount of glucose needed to mimic the OGTT curve during the iv glucose infusion. [ Time Frame: Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with type 1 diabetes mellitus
 Other: Oral glucose tolerance test
50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
Other Names:
  • OGTT
  • 50 g-OGTT
Other: Isoglycemic iv glucose infusion
The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.
Other Name: Isoglycemic IVGTT
2
Healthy control subjects matched for body mass index (BMI), age and gender.
 Other: Oral glucose tolerance test
50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
Other Names:
  • OGTT
  • 50 g-OGTT
Other: Isoglycemic iv glucose infusion
The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.
Other Name: Isoglycemic IVGTT

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with type 1 diabetes mellitus and no residual beta-cell function (C-peptide negative)

Criteria

Inclusion Criteria:

  • Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
  • No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
  • BMI <30 kg/m2
  • Normal haemoglobin
  • Informed consent

Exclusion Criteria:

  • Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
  • Known liver disease or affected liver enzymes (ALAT/ASAT > 2 x upper normal limit)
  • Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuria)
  • Proliferative diabetic retinopathy (anamnestic)
  • Treatment with medication that cannot be discontinued for 14 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704795

Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Filip K Knop, MD PhD University Hospital, Gentofte, Copenhagen
  More Information

No publications provided

Responsible Party: Kristine Juul Hare/MD, Gentofte University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00704795     History of Changes
Other Study ID Numbers: H-D-2008-037
Study First Received: June 24, 2008
Last Updated: June 25, 2008
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Glucagon
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013