A Phase 3 interventional study of Tadalafil and Placebo in Cardiovascular Disease, Insulin Resistance and Glucose Intolerance, sponsored by Thomas J. Wang, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-30.
Sponsored by Thomas J. Wang, MD · Phase 3, Interventional, and Treatment
The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).
This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.
The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.
The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 73 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
20 mg Tadalafil tablet taken by mouth once a day for 3 months
Drug: Tadalafil
Placebo tablet taken by mouth once a day for 3 months
Drug: Placebo
20 mg Tadalafil taken once a day for 3 months
Also known as: Adcirca, Cialis
Placebo tablet taken by mouth once a day for 3 months
Also known as: Sugar pill
Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR
The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \[fasting glucose \* fasting insulin\]/405
Time frame: Baseline and 3 months
Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index
The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT \[fasting glucose\*fasting insulin\* (mean glucose from time 30, 60, 90, 120 min) \* (mean insulin at time 30, 60, 90, and 120 min)\]
Time frame: Baseline and 3 months
Baseline to 3-month Change in Endothelial Function Measured by EndoPAT
Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)
Time frame: Baseline and 3 months
Insulinogenic Index
The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = \[fasting insulin - insulin at time 30 min\] / \[fasting glucose - glucose at time 30 min\]
Time frame: Baseline and 3 months
Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index
The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin
Time frame: Baseline and 3 months
Baseline to 3-month Change in Matsuda Disposition Index
Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = \[Matsuda sensitivity index \* insulinogenic index\]
Time frame: Baseline and 3 months
| Milestone | Tadalafil | Placebo |
|---|---|---|
| Started | 36 | 37 |
| Completed | 25 | 28 |
| Not completed | 11 | 9 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Lost to follow-up | 5 | 5 |
| Withdrew: Non-fasting | 2 | 1 |
| Withdrew: Missing data | 1 | 1 |
The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \[fasting glucose \* fasting insulin\]/405
| mg*microunits/dL*mL | Tadalafil | Placebo |
|---|---|---|
| Baseline | 3.57 ± 2.86 | 3.84 ± 3.80 |
| 3 months | 3.81 ± 5.14 | 5.06 ± 3.95 |
The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT \[fasting glucose\*fasting insulin\* (mean glucose from time 30, 60, 90, 120 min) \* (mean insulin at time 30, 60, 90, and 120 min)\]
| unitless index | Tadalafil | Placebo |
|---|---|---|
| Baseline | 3.60 ± 2.54 | 3.51 ± 2.15 |
| 3 months | 4.27 ± 2.83 | 3.28 ± 2.42 |
Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)
| unitless index | Tadalafil | Placebo |
|---|---|---|
| Baseline | 2.1 ± 0.5 | 2.3 ± 0.6 |
| 3-month | 2.1 ± 2.7 | 2.2 ± 0.3 |
The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = \[fasting insulin - insulin at time 30 min\] / \[fasting glucose - glucose at time 30 min\]
| unitless index | Tadalafil | Placebo |
|---|---|---|
| Baseline | 0.39 ± 8.04 | 2.17 ± 2.06 |
| 3-month | 2.62 ± 3.03 | 1.04 ± 2.32 |
The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin
| unitless index | Tadalafil | Placebo |
|---|---|---|
| Baseline | 1.74 ± 11.56 | 2.87 ± 3.67 |
| 3-month | 4.48 ± 4.62 | 0.58 ± 5.21 |
Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = \[Matsuda sensitivity index \* insulinogenic index\]
| unitless index | Tadalafil | Placebo |
|---|---|---|
| Baseline | 2.23 ± 24.19 | 6.67 ± 9.45 |
| 3-month | 9.22 ± 8.51 | 0.19 ± 18.42 |
Collected over Adverse events recorded during study duration (3 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tadalafil | — | 0/36 (0%) | 7/36 (19.4%) |
| Placebo | — | 0/37 (0%) | 2/37 (5.4%) |
| Event | Tadalafil | Placebo |
|---|---|---|
| HeadacheVascular disorders | 4/36 | 0/37 |
| Back or leg painMusculoskeletal and connective tissue disorders | 2/36 | 0/37 |
| Headache and back acheMusculoskeletal and connective tissue disorders | 1/36 | 0/37 |
| Blurry vision and headacheVascular disorders | 0/36 | 1/37 |
| arm painMusculoskeletal and connective tissue disorders | 0/36 | 1/37 |
| Age, Continuous(years) | Tadalafil | Placebo | Total |
|---|---|---|---|
| Mean | 33 ± 9 | 34 ± 9 | 33 ± 9 |
| Gender(Participants) | Tadalafil | Placebo | Total |
|---|---|---|---|
| Female | 7 | 13 | 20 |
| Male | 18 | 15 | 33 |
| Region of Enrollment(participants) | Tadalafil | Placebo | Total |
|---|---|---|---|
| United States | 25 | 28 | 53 |
| Body mass index(kg/m^2) | Tadalafil | Placebo | Total |
|---|---|---|---|
| Mean | 38.7 ± 6.8 | 36.8 ± 6.8 | 37.7 ± 6.8 |
| Fasting insulin(microunits/mL) | Tadalafil | Placebo | Total |
|---|---|---|---|
| Mean | 17 ± 10 | 17 ± 16 | 17 ± 13 |
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Studies of the drug tested here: Tadalafil