CrpWHEY THANCT06307782
The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level and Healing Quality Before Total Hip Arthroplasty
A study testing whey protein intake before surgery and Water before surgery in people with Crp and Insulin Resistance, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality. Design: It was planned as Randomized Controlled. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crp, Insulin Resistance, Cortisol; Hypersecretion
- What is being tested?
- whey protein intake before surgery and Water before surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2023to 30 Dec 2024
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between the ages of 50-70,
- Spinal anesthesia
- Individuals with a BMI<40,
- Individuals with ASA I, ASA II and ASA III
Who cannot join
- Patients with communication problems
- Individuals with hepatic, renal, endocrine, gastric and neurological disorders
- Any diagnosed psychiatric disease,
- NRS (nutritional risk score )2002 score 3 Individuals with malnutrition and above,
- Allergy to whey and lactose intolerance will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level
Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality.
Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI <40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery.
Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field.
Read the detailed description
Total hip arthroplasty is a frequently performed and highly successful surgical intervention. It is done to relieve pain and improve function in people with advanced arthritis of the hip joint. Symptomatic osteoarthritis is the most common indication for surgery.The number of cases has increased significantly due to the rapidly increasing aging population worldwide. It is estimated that 0.33 million total hip arthroplasty (THA) are performed annually in the United States, and the demand for these surgeries will be 0.57 million in 2030. It is important to establish practical strategies to improve the quality of healthcare for patients undergoing THA and achieve earlier recovery and better outcomes, while also facilitating the reduction of the heavy economic burden associated with healthcare associated with the increased number of procedures. According to the current protocol for total hip arthroplasty, patients are kept in a fasting state from midnight to prevent the risk of pulmonary aspiration during surgery. This condition causes both physical and mental discomfort in patients. This is an old technique that has been practiced for many years. Patients experience a catabolic state after surgery, which can contribute to insulin resistance and hyperglycemia, which can worsen the stress response and prolong recovery time. Prolonged fasting in the perioperative period slows down metabolism and induces insulin resistance. Avoiding long-term fasting and metabolic satiety before surgery significantly reduces postoperative insulin resistance and also has beneficial effects on postoperative glucose and protein metabolism. Metabolic satiety prevents early feeding, preserving muscle mass and less hyperglycemia in patients. Adequate nutritional intake before and after surgery significantly reduces surgical stress and accelerates functional recovery. After whey is consumed, it passes quickly through the stomach and reaches the jejunum as intact proteins, and as clots form in the acid environment, the release of casein from the stomach is delayed. After peptic hydrolysis, peptides are released into the small intestine. It has been reported that the hydrolysis of whey in the small intestine is slow compared to other proteins, and their digestion and absorption occur over a longer intestinal length. It has been found that whey reduces food intake more at 90 minutes, but casein has a stronger effect later (at 150 minutes). It has many physiological functions, including regulating systems. However, these actions are not limited to whey proteins and peptides alone, but also result from the synergy between whey proteins and other whey components such as calcium. The effect of the proteins found in whey on satiety and food intake has an effect on the release of satiety hormones. Insulin plays a role in both short-term and long-term regulation of food intake. In the study conducted, whey plus carbohydrate drink was drunk 6 and 3 hours before surgery. Postoperative CRP (C reactive protein), albumin and insulin resistance were found to decrease significantly in those who drank whey. In a study conducted in which perioperative 2-hour fasting was administered to patients undergoing maxillofacial surgery, glutamine and oral carbohydrate solution were found to reduce postoperative insulin resistance.Whey, which will be used in this study, is easy to digest and absorb. Whey components contain significant amounts of milk proteins and their properties. The main protein of milk is casein, approximately 80% of the proteins in milk consist of whey, and the proteins in milk contain approximately 20% of the proteins. In this planned study, the effect of oral whey on postoperative surgical stress and inflammatory responses will be investigated by giving oral whey before total hip arthroplasty.
- Being tested
- whey protein intake before surgery, Water before surgery
- Keywords
- whey, Total Hip Arthroplasty, inflammatory, Stress, Insulin Resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein intake before surgeryDietary supplement
Total Hip Arthroplasty whey protein intake,Total Hip Arthroplasty, whey protein intake,CRP,cortisol insulin resistance
Water before surgeryDietary supplement
Total Hip Arthroplasty water before surgery,Total Hip Arthroplasty, water intake,CRP,cortisol insulin resistance
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty, whey protein intake, | Experimental | In the ERAS (Enhanced Recovery After Surgery) protocol, preoperative oral carbohydrate intake must be at least 45 g. While preparing the whey mixture, 60 grams of whey powder will be mixed into 600ml bottled water to obtain a mixture worth 200 kcal. Whey will be prepared and given by the researcher at the bedside in room air using bottled water.
In this study, by scanning the literature (13) and taking expert opinion (dietitian, anesthesiologist, orthopedic doctor), the individuals in the intervention group were given 6 hours after the surgery. It is planned to drink 600ml oral whey powder water first. Receives: Dietary Supplement: whey protein intake before surgery |
| Total Hip Arthroplasty, water intake | Active comparator | 600ml of water will be given 6 hours before the surgery. Receives: Dietary Supplement: Water before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of C Reactive Protein
physiological parameter, questionnaire
Measured: 24 hour
Rate of insulin resistance
physiological parameter, questionnaire
Measured: 24 hour
Rate of albumen
physiological parameter, questionnaire
Measured: 24 hour
Rate of cortisol
physiological parameter, questionnaire
Measured: 24 hour
Healing Quality
Quality of Recovery-15 scala
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 posted13 Mar 2024
- Study start25 Jun 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CrpStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize control trials
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜMEYRA YÜKSEL, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307782
- Sponsor's protocol ID
- 12833
- Acronym
- WHEY THA
- Status last verified
- Mar 2024
- First submitted
- 6 Jan 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: randomize clinical study
Publications
1.Ferguson R, Palmer A, Taylor A, Porter M, Malchau H, Jones S,G(2018). Hip replacement. Lancet.392(10158):1662-1671 2.Kurtz S, Ong K, Lau E, Mowat F, Halpern M(2007). 2005'ten 2030'a kadar Amerika Birleşik Devletleri'nde primer ve revizyon kalça ve diz artroplastisinin projeksiyonları. J Bone Joint Surg Am; 89 :780-785. 3. Kaye A, Urman R, Cornett E, Hart B, Chami A, Gayle J, et al(2019). Ortopedik cerrahide geliştirilmiş iyileşme yolları. J Anesteziol Clin Pharmacol.; 35 :35-39. 4. Kehlet H(1997). Postoperatif patofizyoloji ve rehabilitasyonu kontrol etmek için multimodal yaklaşım. Br J Anaesth.; 78 :606-617. 5.Nygren J (2006). The metabolic effects of fasting and surgery. Best Practice & Research Clinical Anaesthesiology.20(3):429-438 6. Luhovyy BL, Akhavan T, Anderson GH. Whey proteins in the regulation of food intake and satiety. J Am Coll Nutr. 2007;26(6):704S-12S. doi:10.1080/07315724.2007.10719651 7. Zemel MB. Mechanisms of dairy modulation of adiposity. J. Nutr.2003;133:252S-256S 8. Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, LealFS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, da Aguilar-Nascimento JE(2011). Effects ofpreoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J.;10:66. 9. Singh M, Chaudhary M, Vashistha A, Kaur G (2015). Evaluation of effects of a preoperative 2-hour fast with glutamine and carbohydrate rich drink on insulin resistance in maxillofacial surgery. J Oral Biol Craniofac Res.5(1):34-9 10. Güzeler N, Esmek E,M, & Kalender M (2017). Peyniraltı Suyu ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Gıda Bil. Der.32(2);27-36
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level
- ClinicalTrials.gov ID
- NCT06307782
- Acronym / sponsor ID
- WHEY THA / 12833
- Keywords
- whey, Total Hip Arthroplasty, inflammatory, Stress, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Mar 2024 (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.
Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality.
Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI <40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery.
Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field.
Detailed description
Total hip arthroplasty is a frequently performed and highly successful surgical intervention. It is done to relieve pain and improve function in people with advanced arthritis of the hip joint. Symptomatic osteoarthritis is the most common indication for surgery.The number of cases has increased significantly due to the rapidly increasing aging population worldwide. It is estimated that 0.33 million total hip arthroplasty (THA) are performed annually in the United States, and the demand for these surgeries will be 0.57 million in 2030. It is important to establish practical strategies to improve the quality of healthcare for patients undergoing THA and achieve earlier recovery and better outcomes, while also facilitating the reduction of the heavy economic burden associated with healthcare associated with the increased number of procedures. According to the current protocol for total hip arthroplasty, patients are kept in a fasting state from midnight to prevent the risk of pulmonary aspiration during surgery. This condition causes both physical and mental discomfort in patients. This is an old technique that has been practiced for many years. Patients experience a catabolic state after surgery, which can contribute to insulin resistance and hyperglycemia, which can worsen the stress response and prolong recovery time. Prolonged fasting in the perioperative period slows down metabolism and induces insulin resistance. Avoiding long-term fasting and metabolic satiety before surgery significantly reduces postoperative insulin resistance and also has beneficial effects on postoperative glucose and protein metabolism. Metabolic satiety prevents early feeding, preserving muscle mass and less hyperglycemia in patients. Adequate nutritional intake before and after surgery significantly reduces surgical stress and accelerates functional recovery. After whey is consumed, it passes quickly through the stomach and reaches the jejunum as intact proteins, and as clots form in the acid environment, the release of casein from the stomach is delayed. After peptic hydrolysis, peptides are released into the small intestine. It has been reported that the hydrolysis of whey in the small intestine is slow compared to other proteins, and their digestion and absorption occur over a longer intestinal length. It has been found that whey reduces food intake more at 90 minutes, but casein has a stronger effect later (at 150 minutes). It has many physiological functions, including regulating systems. However, these actions are not limited to whey proteins and peptides alone, but also result from the synergy between whey proteins and other whey components such as calcium. The effect of the proteins found in whey on satiety and food intake has an effect on the release of satiety hormones. Insulin plays a role in both short-term and long-term regulation of food intake. In the study conducted, whey plus carbohydrate drink was drunk 6 and 3 hours before surgery. Postoperative CRP (C reactive protein), albumin and insulin resistance were found to decrease significantly in those who drank whey. In a study conducted in which perioperative 2-hour fasting was administered to patients undergoing maxillofacial surgery, glutamine and oral carbohydrate solution were found to reduce postoperative insulin resistance.Whey, which will be used in this study, is easy to digest and absorb. Whey components contain significant amounts of milk proteins and their properties. The main protein of milk is casein, approximately 80% of the proteins in milk consist of whey, and the proteins in milk contain approximately 20% of the proteins. In this planned study, the effect of oral whey on postoperative surgical stress and inflammatory responses will be investigated by giving oral whey before total hip arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomize control trials
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty, whey protein intake, | Experimental | Dietary Supplement: whey protein intake before surgeryIn the ERAS (Enhanced Recovery After Surgery) protocol, preoperative oral carbohydrate intake must be at least 45 g. While preparing the whey mixture, 60 grams of whey powder will be mixed into 600ml bottled water to obtain a mixture worth 200 kcal. Whey will be prepared and given by the researcher at the bedside in room air using bottled water. In this study, by scanning the literature (13) and taking expert opinion (dietitian, anesthesiologist, orthopedic doctor), the individuals in the intervention group were given 6 hours after the surgery. It is planned to drink 600ml oral whey powder water first. |
| Total Hip Arthroplasty, water intake | Active comparator | Dietary Supplement: Water before surgery600ml of water will be given 6 hours before the surgery. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals between the ages of 50-70,
- Spinal anesthesia
- Individuals with a BMI<40,
- Individuals with ASA I, ASA II and ASA III
Key exclusion criteria (5 listed)
- Patients with communication problems
- Individuals with hepatic, renal, endocrine, gastric and neurological disorders
- Any diagnosed psychiatric disease,
- NRS (nutritional risk score )2002 score 3 Individuals with malnutrition and above,
- Allergy to whey and lactose intolerance will be excluded from 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 |
|---|---|---|
| whey protein intake before surgeryTotal Hip Arthroplasty whey protein intake,Total Hip Arthroplasty, whey protein intake,CRP,cortisol insulin resistance | Dietary supplement | Total Hip Arthroplasty, whey protein intake, |
| Water before surgeryTotal Hip Arthroplasty water before surgery,Total Hip Arthroplasty, water intake,CRP,cortisol insulin resistance | Dietary supplement | Total Hip Arthroplasty, water intake |
Primary outcome
Rate of C Reactive Protein
Time frame: 24 hour
physiological parameter, questionnaire
Rate of insulin resistance
Time frame: 24 hour
physiological parameter, questionnaire
Rate of albumen
Time frame: 24 hour
physiological parameter, questionnaire
Rate of cortisol
Time frame: 24 hour
physiological parameter, questionnaire
Healing Quality
Time frame: 24 hour
Quality of Recovery-15 scala
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background1.Ferguson R, Palmer A, Taylor A, Porter M, Malchau H, Jones S,G(2018). Hip replacement. Lancet.392(10158):1662-1671 2.Kurtz S, Ong K, Lau E, Mowat F, Halpern M(2007). 2005'ten 2030'a kadar Amerika Birleşik Devletleri'nde primer ve revizyon kalça ve diz artroplastisinin projeksiyonları. J Bone Joint Surg Am; 89 :780-785. 3. Kaye A, Urman R, Cornett E, Hart B, Chami A, Gayle J, et al(2019). Ortopedik cerrahide geliştirilmiş iyileşme yolları. J Anesteziol Clin Pharmacol.; 35 :35-39. 4. Kehlet H(1997). Postoperatif patofizyoloji ve rehabilitasyonu kontrol etmek için multimodal yaklaşım. Br J Anaesth.; 78 :606-617. 5.Nygren J (2006). The metabolic effects of fasting and surgery. Best Practice & Research Clinical Anaesthesiology.20(3):429-438 6. Luhovyy BL, Akhavan T, Anderson GH. Whey proteins in the regulation of food intake and satiety. J Am Coll Nutr. 2007;26(6):704S-12S. doi:10.1080/07315724.2007.10719651 7. Zemel MB. Mechanisms of dairy modulation of adiposity. J. Nutr.2003;133:252S-256S 8. Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, LealFS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, da Aguilar-Nascimento JE(2011). Effects ofpreoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J.;10:66. 9. Singh M, Chaudhary M, Vashistha A, Kaur G (2015). Evaluation of effects of a preoperative 2-hour fast with glutamine and carbohydrate rich drink on insulin resistance in maxillofacial surgery. J Oral Biol Craniofac Res.5(1):34-9 10. Güzeler N, Esmek E,M, & Kalender M (2017). Peyniraltı Suyu ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Gıda Bil. Der.32(2);27-36
- Individual participant dataSharing planned: No. randomize clinical study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein intake before surgery and Water before surgery in people with Crp and Insulin Resistance, run by TC Erciyes 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of C Reactive Protein (time frame: 24 hour). The study lists 5 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 NCT06307782, which also lists 1 linked publication.
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 11 Feb 2025.