| CTRI Number |
CTRI/2025/08/092351 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Timing of Telmisartan (40 mg) for Treating High Blood Pressure in Diabetic Patients: A Study of Blood Pressure Changes During Exercise and Monitoring Through the Day |
|
Scientific Title of Study
|
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.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NALABOTHULA RAVITEJA |
| Designation |
post graduate in general medicine |
| Affiliation |
srm medical collage and research centre |
| Address |
H Block Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7032134769 |
| Fax |
|
| Email |
raviat8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Nanda Kumar |
| Designation |
professor general medicine |
| Affiliation |
srm medical collage and research centre |
| Address |
H Block Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8667741559 |
| Fax |
|
| Email |
nandakur@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nalabothula Raviteja |
| Designation |
post graduate in general medicine |
| Affiliation |
srm medical collage and research centre |
| Address |
H Block Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7032134769 |
| Fax |
|
| Email |
raviat8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu , india, pincode 603203. |
|
|
Primary Sponsor
|
| Name |
department of general medicine |
| Address |
H Block Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu, india. pincode 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nalabothula Raviteja |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre
H Block Department of General Medicine, SRM Medical College Hospital and Research Centre
Kattankulathur, tamilnadu, india. pin code 603203
Kancheepuram
TAMIL NADU |
7032134769
raviat8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital - Students Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bedtime dosing of telmisartan 40mg |
Based upon inclusion and
exclusion criteria, patient will be
started on Tablet Telmisartan 40mg per oral at bedtime for 8 weeks |
| Intervention |
Daytime dosing of telmimsartan 40mg |
Based upon inclusion and
exclusion criteria, patient will be
started on Tablet telmisartan 40mg per oral in the morning for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged over 18 years
2. Diagnosed with both diabetes and hypertension
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morning Versus Bedtime Dosing Of Antihypertensive In Diabetic Hypertensive Patients |
4 months 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to identify nocturnal dipping pattern |
4 months 10 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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: - Phase 1 (8 Weeks): Group A received telmisartan in the morning, while Group B received it at bedtime.
- Washout Period (1 Week): During this interval, patients received either calcium channel blockers (CCBs) or thiazides to manage hypertension.
- 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.
|