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

NCT00704795 | Unknown

• 1 other identifier: H-D-2008-037
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglucagonemia; Hyperglycemia; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.

  months

Secondary Outcomes (2)

• 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.

  months

• 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.

  Months

Study Arms (2)

1

Patients with type 1 diabetes mellitus

Other: Oral glucose tolerance test; Other: Isoglycemic iv glucose infusion

2

Healthy control subjects matched for body mass index (BMI), age and gender.

Other: Oral glucose tolerance test; Other: Isoglycemic iv glucose infusion

Interventions

Oral glucose tolerance test OTHER

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).

Also known as: OGTT, 50 g-OGTT

1; 2

Isoglycemic iv glucose infusion OTHER

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.

Also known as: Isoglycemic IVGTT

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte University Hospital

Hellerup, Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Filip K Knop, MD PhD

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 25, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 26, 2008

Record last verified: 2008-06

Locations

DK (1)