Diabetes Mellitus, Type 2NCT04477694
The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia
An observational study of Diabetes Mellitus, Type 2 and Sedoanalgesia, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients are recommended to have colonoscopy frequently. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Sedoanalgesia
- What is being tested?
- colonoscopy under sedoanalgesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type II diabetic and non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia
Who may be able to join
- Female patients aged between 18-65 years old
- Type II diabetic and non-diabetic
Who cannot join
- Age outside the range of 18-65 years
- ASA phsical status ≥ 3
- Inability to provide informed consent
- Pregnancy
- Previous adverse reactions to medications used in the study
- History of anesthesia and sedation in the last 7 days
Show all 11Show fewer
- Psychiatric or emotional disorders
- Addiction to the opioids or sedatives used in the study
- Diabetic nephrophathy, high BUN and creatinine values
- Advanced stages of diabetic nonalcoholic liver disease and high liver function tests
- Diabetic sensorymotor and autonomic neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Zubeyde Hanim Practice and Research Center
Izmir, Karşıyaka, 35540
Özvardar Pekcan, +90 232 2411000 ext. 1085, yncapek@gmail.com
Tuncalı, +90 232 2411000 ext. 1260, tuncali.bahattin@gmail.com
About this study
Official title: The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia
INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients are recommended to have colonoscopy frequently. The aim of this study is to search the effect of DM on hemodynamics, procedure times, anesthetic consumption and complications in colonoscopy under sedoanalgesia.
MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of Başkent University, this study is planned to be prospective and double-blind in 50 type II diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of 18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy, previous adverse reactions to medications used in the study, history of anesthesia and sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic sensorymotor and autonomic neuropathy.
Read more
After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2, respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other effects will be recorded.
EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that diabetic patients have during colonoscopy and applying a special patient care protocol for these patients is suggested to improve the procedure and outcomes.
- Conditions
- Diabetes Mellitus, Type 2, Sedoanalgesia
- Being tested
- colonoscopy under sedoanalgesia
- Keywords
- Diabetes mellitus, Sedoanalgesia, Colonoscopy under sedoanalgesia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy under sedoanalgesiaProcedure or surgery
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
| Study group | Role | What they receive |
|---|---|---|
| type II diabetic patients | Not described Receives: Procedure: colonoscopy under sedoanalgesia | |
| non-diabetic patients | Not described Receives: Procedure: colonoscopy under sedoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied mean blood pressure will be recorded.
Measured: 24 hour
Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied heart rate will be recorded.
Measured: 24 hour
Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied SpO2 will be recorded.
Measured: 24 hour
Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied respiratuar rate will be recorded.
Measured: 24 hour
Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied Ramsay sedation score level will be recorded. Ramsay sedation score level will be 3 during the process. When the score level is 2, at the end of the procedure, it will be taken to the postoperative intensive care unite.
Measured: 24 hour
Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied modified post anaesthetic discharge score level will be recorded. Patients will be discharged when the score level is 9 or above.
Measured: 24 hour
Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied procedure times will be recorded.
Measured: 24 hour
Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied total anaesthetic doses will be recorded.
Measured: 24 hour
Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
After sedoanalgesia is applied stomach ache and other effects will be recorded. Stomach ache will be evaluated by visuel analog pain scale. When it is 4 or above, will be considered meaningful.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start27 Dec 2020
- Primary completion30 Nov 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonca Özvardar Pekcan, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477694
- Sponsor's protocol ID
- K19/320
- Status last verified
- Mar 2023
- First submitted
- 29 Jun 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PubMed 29496507Zhao G, Ford ES, Ahluwalia IB, Li C, Mokdad AH. Prevalence and trends of receipt of cancer screenings among US women with diagnosed diabetes. J Gen Intern Med. 2009 Feb;24(2):270-5. doi: 10.1007/s11606-008-0858-8. Epub 2008 Dec 17.
PubMed 19089511Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus report. Diabetes Care. 2010 Jul;33(7):1674-85. doi: 10.2337/dc10-0666.
PubMed 20587728Noto H, Tsujimoto T, Sasazuki T, Noda M. Significantly increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis. Endocr Pract. 2011 Jul-Aug;17(4):616-28. doi: 10.4158/EP10357.RA.
PubMed 21454235Yang X, Ko GT, So WY, Ma RC, Yu LW, Kong AP, Zhao H, Chow CC, Tong PC, Chan JC. Associations of hyperglycemia and insulin usage with the risk of cancer in type 2 diabetes: the Hong Kong diabetes registry. Diabetes. 2010 May;59(5):1254-60. doi: 10.2337/db09-1371. Epub 2010 Feb 25.
PubMed 20185812Renehan AG, Zwahlen M, Minder C, O'Dwyer ST, Shalet SM, Egger M. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet. 2004 Apr 24;363(9418):1346-53. doi: 10.1016/S0140-6736(04)16044-3.
PubMed 15110491Diaz-Algorri Y, Lozada ME, Lopez SM, Bertran-Rodriguez CE, Gonzalez-Hernandez CM, Gonzalez D, Perez-Cardona CM, Hernandez J, Pedrosa C, Toro DH, Gonzalez-Pons M, Cruz-Correa M. Type 2 diabetes mellitus and colorectal neoplasia risk in Hispanics: a case-control study. J Diabetes Complications. 2015 May-Jun;29(4):502-7. doi: 10.1016/j.jdiacomp.2015.01.010. Epub 2015 Feb 3.
PubMed 25784088Vu HT, Ufere N, Yan Y, Wang JS, Early DS, Elwing JE. Diabetes mellitus increases risk for colorectal adenomas in younger patients. World J Gastroenterol. 2014 Jun 14;20(22):6946-52. doi: 10.3748/wjg.v20.i22.6946.
PubMed 24944487Kanadiya MK, Gohel TD, Sanaka MR, Thota PN, Shubrook JH Jr. Relationship between type-2 diabetes and use of metformin with risk of colorectal adenoma in an American population receiving colonoscopy. J Diabetes Complications. 2013 Sep-Oct;27(5):463-6. doi: 10.1016/j.jdiacomp.2013.04.010. Epub 2013 Jun 5.
PubMed 23755906Suh S, Kang M, Kim MY, Chung HS, Kim SK, Hur KY, Kim JH, Lee MS, Lee MK, Kim KW. Korean type 2 diabetes patients have multiple adenomatous polyps compared to non-diabetic controls. J Korean Med Sci. 2011 Sep;26(9):1196-200. doi: 10.3346/jkms.2011.26.9.1196. Epub 2011 Sep 1.
PubMed 21935276Giouleme O, Diamantidis MD, Katsaros MG. Is diabetes a causal agent for colorectal cancer? Pathophysiological and molecular mechanisms. World J Gastroenterol. 2011 Jan 28;17(4):444-8. doi: 10.3748/wjg.v17.i4.444.
PubMed 21274373Erbach M, Mehnert H, Schnell O. Diabetes and the risk for colorectal cancer. J Diabetes Complications. 2012 Jan-Feb;26(1):50-5. doi: 10.1016/j.jdiacomp.2011.11.003. Epub 2012 Feb 7.
PubMed 22321219Laish I, Mizrahi J, Naftali T, Konikoff FM. Diabetes Mellitus and Age are Risk Factors of Interval Colon Cancer: A Case-Control Study. Dig Dis. 2019;37(4):291-296. doi: 10.1159/000496740. Epub 2019 Feb 7.
PubMed 30731459Fanti L, Testoni PA. Sedation and analgesia in gastrointestinal endoscopy: what's new? World J Gastroenterol. 2010 May 28;16(20):2451-7. doi: 10.3748/wjg.v16.i20.2451.
PubMed 20503443Cornelius BW. Patients With Type 2 Diabetes: Anesthetic Management in the Ambulatory Setting. Part 1: Pathophysiology and Associated Disease States. Anesth Prog. 2016 Winter;63(4):208-215. doi: 10.2344/0003-3006-63.4.208.
PubMed 27973934
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia
- ClinicalTrials.gov ID
- NCT04477694
- Acronym / sponsor ID
- K19/320
- Conditions
- Diabetes Mellitus, Type 2, Sedoanalgesia
- Keywords
- Diabetes mellitus, Sedoanalgesia, Colonoscopy under sedoanalgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients are recommended to have colonoscopy frequently. The aim of this study is to search the effect of DM on hemodynamics, procedure times, anesthetic consumption and complications in colonoscopy under sedoanalgesia.
MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of Başkent University, this study is planned to be prospective and double-blind in 50 type II diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of 18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy, previous adverse reactions to medications used in the study, history of anesthesia and sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic sensorymotor and autonomic neuropathy.
After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2, respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other effects will be recorded.
EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that diabetic patients have during colonoscopy and applying a special patient care protocol for these patients is suggested to improve the procedure and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type II diabetic patients | – | Procedure: colonoscopy under sedoanalgesia |
| non-diabetic patients | – | Procedure: colonoscopy under sedoanalgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type II diabetic and non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia
Key inclusion criteria (2 listed)
- Female patients aged between 18-65 years old
- Type II diabetic and non-diabetic
Key exclusion criteria (11 listed)
- Age outside the range of 18-65 years
- ASA phsical status ≥ 3
- Inability to provide informed consent
- Pregnancy
- Previous adverse reactions to medications used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy under sedoanalgesiaColonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera. | Procedure or surgery | non-diabetic patients, type II diabetic patients |
Primary outcome
Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied mean blood pressure will be recorded.
Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied heart rate will be recorded.
Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied SpO2 will be recorded.
Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied respiratuar rate will be recorded.
Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied Ramsay sedation score level will be recorded. Ramsay sedation score level will be 3 during the process. When the score level is 2, at the end of the procedure, it will be taken to the postoperative intensive care unite.
Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied modified post anaesthetic discharge score level will be recorded. Patients will be discharged when the score level is 9 or above.
Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied procedure times will be recorded.
Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied total anaesthetic doses will be recorded.
Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
Time frame: 24 hour
After sedoanalgesia is applied stomach ache and other effects will be recorded. Stomach ache will be evaluated by visuel analog pain scale. When it is 4 or above, will be considered meaningful.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 29496507Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
- Background: PubMed 19089511Zhao G, Ford ES, Ahluwalia IB, Li C, Mokdad AH. Prevalence and trends of receipt of cancer screenings among US women with diagnosed diabetes. J Gen Intern Med. 2009 Feb;24(2):270-5. doi: 10.1007/s11606-008-0858-8. Epub 2008 Dec 17.
- Background: PubMed 20587728Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus report. Diabetes Care. 2010 Jul;33(7):1674-85. doi: 10.2337/dc10-0666.
- Background: PubMed 21454235Noto H, Tsujimoto T, Sasazuki T, Noda M. Significantly increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis. Endocr Pract. 2011 Jul-Aug;17(4):616-28. doi: 10.4158/EP10357.RA.
- Background: PubMed 20185812Yang X, Ko GT, So WY, Ma RC, Yu LW, Kong AP, Zhao H, Chow CC, Tong PC, Chan JC. Associations of hyperglycemia and insulin usage with the risk of cancer in type 2 diabetes: the Hong Kong diabetes registry. Diabetes. 2010 May;59(5):1254-60. doi: 10.2337/db09-1371. Epub 2010 Feb 25.
- Background: PubMed 15110491Renehan AG, Zwahlen M, Minder C, O'Dwyer ST, Shalet SM, Egger M. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet. 2004 Apr 24;363(9418):1346-53. doi: 10.1016/S0140-6736(04)16044-3.
- Background: PubMed 25784088Diaz-Algorri Y, Lozada ME, Lopez SM, Bertran-Rodriguez CE, Gonzalez-Hernandez CM, Gonzalez D, Perez-Cardona CM, Hernandez J, Pedrosa C, Toro DH, Gonzalez-Pons M, Cruz-Correa M. Type 2 diabetes mellitus and colorectal neoplasia risk in Hispanics: a case-control study. J Diabetes Complications. 2015 May-Jun;29(4):502-7. doi: 10.1016/j.jdiacomp.2015.01.010. Epub 2015 Feb 3.
- Background: PubMed 24944487Vu HT, Ufere N, Yan Y, Wang JS, Early DS, Elwing JE. Diabetes mellitus increases risk for colorectal adenomas in younger patients. World J Gastroenterol. 2014 Jun 14;20(22):6946-52. doi: 10.3748/wjg.v20.i22.6946.
- Background: PubMed 23755906Kanadiya MK, Gohel TD, Sanaka MR, Thota PN, Shubrook JH Jr. Relationship between type-2 diabetes and use of metformin with risk of colorectal adenoma in an American population receiving colonoscopy. J Diabetes Complications. 2013 Sep-Oct;27(5):463-6. doi: 10.1016/j.jdiacomp.2013.04.010. Epub 2013 Jun 5.
- Background: PubMed 21935276Suh S, Kang M, Kim MY, Chung HS, Kim SK, Hur KY, Kim JH, Lee MS, Lee MK, Kim KW. Korean type 2 diabetes patients have multiple adenomatous polyps compared to non-diabetic controls. J Korean Med Sci. 2011 Sep;26(9):1196-200. doi: 10.3346/jkms.2011.26.9.1196. Epub 2011 Sep 1.
- Background: PubMed 21274373Giouleme O, Diamantidis MD, Katsaros MG. Is diabetes a causal agent for colorectal cancer? Pathophysiological and molecular mechanisms. World J Gastroenterol. 2011 Jan 28;17(4):444-8. doi: 10.3748/wjg.v17.i4.444.
- Background: PubMed 22321219Erbach M, Mehnert H, Schnell O. Diabetes and the risk for colorectal cancer. J Diabetes Complications. 2012 Jan-Feb;26(1):50-5. doi: 10.1016/j.jdiacomp.2011.11.003. Epub 2012 Feb 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Sedoanalgesia, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonca Özvardar Pekcan (+90 232 2411000 ext. 1085, yncapek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia (time frame: 24 hour). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477694, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.