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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01048268
Enrollment
30
Registered
2010-01-13
Start date
2009-12-31
Completion date
2014-04-30
Last updated
2015-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

T1DM, T2DM, GIP, Glucose-dependent insulinotropic polypeptide, Incretin

Brief summary

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

Detailed 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.

Interventions

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

DRUGPlacebo

copy GIP infusion rates

Sponsors

University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
The difference between the amount of infused glucose and the insulin responseswill be measured at each visit

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026