Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect
Brief summary
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.
Interventions
DRUGSulfonylurea
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus diagnosed according to WHO criteria * Diet and/or metformin treatment * HbA1c \> 7,0% for metformin treated patients * HbA1c \> 7,5% for diet treated patients * Age: 18 years or older * 25 \> BMI \> 40 kg/m2 * Signed informed consent * Sufficient birth control in case of child bearing capacity
Exclusion criteria
* Proliferative retinopathy * Diabetic nephropathy with s-creatinine \> 130 microM and/or macroalbuminuria * Liver disease (ALAT \> 2 x normal value) * CAD (NYHA group III or IV) * Positive screening for islet-cell and/or GAD-65 autoantibodies * Type 1 diabetes i first degree relatives * Gastrointestinal surgery with intestinal resection * Anemia * Pregnancy and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion | 0 - 90 minutes | area under the curve AUC and insulin secretion rate |
Countries
Denmark
Participant flow
Recruitment details
May 2006 - March 2007, Outpatient clinic and advertisement
Participants by arm
| Arm | Count |
|---|---|
| Sulfonylurea | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Sulfonylurea |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment Denmark | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Insulin Secretion
area under the curve AUC and insulin secretion rate
Time frame: 0 - 90 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sulfonylurea | Insulin Secretion | 56766 pmol/l * 90 minutes |