| Trial ID: | L2893 |
| Source ID: | NCT02601989
|
| Associated Drug: |
Tadalafil
|
| Title: |
Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study
|
| Acronym: |
MAKROTAD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Tadalafil|DRUG: Placebo
|
| Outcome Measures: |
Primary: insulin sensitivity, To evaluate the effect (difference in glucose disposal rate (mg/kg/min)) of daily administration of 20 mg tadalafil for 6 weeks ("chronic" treatment) on insulin sensitivity in muscle by assessing glucose disposal rate during a 3-hour euglycemic hyperinsulinemic glucose clamp (120 mU/m2/min) in T2D patients, 6 week treatment with drug or placebo | Secondary: Mean glucose (HbA1c, mmol/mol) in blood, Evaluation the effect of chronic tadalafil treatment on glucose metabolism and beta-cell function as measured by mean blood glucose (HbA1c), Up to 6 weeks after start of treatment.|Fasting plasma glucose levels (mmol/l), Evaluation the effect of chronic tadalafil treatment on glucose metabolism and beta-cell function as measured by circulating glucose levels, Up to 6 weeks after start of treatment.|Arginine-induced insulin secretion (area under curve, AUC, mU/l/min) in blood, Glucose metabolism and beta-cell function as measured by arginine-induced insulin secretion (difference in AUC, mU/l/min)., 3 weeks after start of treatment.|Levels interstitial insulin, levels interstitial insulin (mU/l), Up to 6 weeks after start of treatment.|Lactate concentrations in insulin sensitive tissues, Lactate concentrations (micromoles/l) in insulin sensitive tissues, Up to 6 weeks after start of treatment.|Levels of inflammatory markers in blood, Difference in endothelin-1 levels (pg/ml), Up to 6 weeks after start of treatment.|Endothelial function in peripheral arteries measured with EndoPAT, measured as difference in reactive hyperemia, 3 weeks after start of treatment.
|
| Sponsor/Collaborators: |
Sponsor: Göteborg University | Collaborators: Vastra Gotaland Region
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2015-11
|
| Completion Date: |
2019-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-02-11
|
| Locations: |
Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT02601989
|
