Chronotherapy of hypertension with telmisartan 40 mg in diabetic hypertensive patients using ambulatory blood pressure monitoring and evaluation of blood pressure response during treadmill exercise: a cross-over randomized controlled trial.

40 patients with type 2 diabetes mellitus and hypertension, aged 40–80 years are to selected. Inclusion criteria required patients to have well-documented hypertension, with no secondary causes, and stable glycemic control with HbA1C %. Patients were excluded if they had significant cardiac abnormalities detected by 2D echocardiography (2D Echo), renal insufficiency, hepatic dysfunction, or were on other angiotensin receptor blockers (ARBs).

Randomization and Study Phases Participants were randomized into two groups:

• Group A: Morning dosing of Telmisartan 40 mg.
• Group B: Bedtime dosing of Telmisartan 40 mg.

The study was conducted in two phases:

1. Phase 1 (8 Weeks): Group A received telmisartan in the morning, while Group B received it at bedtime.
2. Washout Period (1 Week): During this interval, patients received either calcium channel blockers (CCBs) or thiazides to manage hypertension.
3. Phase 2 (8 Weeks): Group A was switched to bedtime dosing, and Group B to morning dosing.

• Ambulatory Blood Pressure Monitoring (ABPM): BP readings were recorded over 24 hours using ABPM devices at baseline and at the end of each study phase. Key parameters included mean daytime SBP/DBP and nighttime SBP/DBP.
• Treadmill Exercise Testing: BP responses during exercise were assessed using the Bruce protocol, which includes incremental stages of increasing intensity. The test was performed at baseline, after Phase 1, and after Phase 2. BP at peak exercise (maximum effort) was recorded.