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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048268
• Other study ID #: GIP HYPO (MC)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 12, 2010
• Last updated: July 10, 2015
• Start date: December 2009
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• Placebo
copy GIP infusion rates

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine F' laboratory	Hellerup	Copenhagen County

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		-10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit	No
Secondary	The difference between the amount of infused glucose and the insulin responses		will be measured at each visit	No