An Early Phase 1 interventional study of Montelukast and Montelukast Placebo in Type 2 Diabetes, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Colorado, Denver · Early Phase 1, Interventional, and Treatment
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Montelukast
Drug: Montelukast Placebo
montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
one microcrystalline cellulose tablet daily
Change in renal vascular resistance (RVR)
Change in RVR from baseline to 6 months. RVR is calculated as mean arterial pressure (MAP)/renal blood flow (RBF). MAP is measured using a blood pressure cuff and RBF is calculated using p-aminohippurate clearance (PAH clearance).
Time frame: 0 and 6 months
Change in Brachial artery flow mediated dilation (FMD)
Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography
Time frame: 0 and 6 months
Change in aortic pulse-wave velocity (PWV)
Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer
Time frame: 0 and 6 months
Change in endovascular biopsy
Change in endovascular biopsy from baseline to 6 months. Venous endothelial cells will be collected from the intima of the vessel using 2 sterile J-wires advanced and retracted through an 18-gauge catheter, then will be incubated with monoclonal antibodies for Nf-KB.
Time frame: 0 and 6 months
Change in urinary sCD163
Time frame: 0 and 6 months
Change in urinary MCP-1
Time frame: 0 and 6 months
Change in plasma MCP-1
Time frame: 0 and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.
Of 62 non-industry phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 50 months is above that.
Counting every sponsor, half of 514 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Aug 2026 → Oct 2026, primary completion Feb 2030 → Dec 2030 and completion Feb 2030 → Dec 2031.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Montelukast
University of Colorado, Denver →