DiabetesNCT03070106
Diabetes: Functional Medicine Approach Vs. Usual Care
A study testing Functional Medicine in people with Diabetes and Type 2 Diabetes, run by Keren Zhou at 1 site in United States.
Trial summary
A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the etiologies for "imbalances in the core physiological systems."(1) If underlying triggers and imbalances can be identified, the FM approach to addressing "root causes"(1) can be utilized through the use of specialized testing… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated with Insulin
- What is being tested?
- Functional Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2017to 1 Feb 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seen in the Cleveland Clinic Main Campus Endocrinology Clinics
- Diagnosis of Type 2 Diabetes
- Insulin treatment for at least 12 months, but for less than 96 months
- Total Daily Insulin Dose <= 150 units
Who cannot join
- Positive glutamate decarboxylase antibody
- C peptide < 0.8 ng/ml
- Use of Insulin Pump for diabetes treatment
- HbA1c > 12%
- History of Diabetic Ketoacidosis (DKA) defined by patient report or any emergency department visits or hospitalization for DKA
- Pregnancy
Show all 19Show fewer
- Breastfeeding
- Known diagnosis of Cognitive Impairment or Dementia
- Estimated Glomerular Filtration Rate < 45 ml/min/1.73m
- Congestive Heart Failure New York Heart Association (NYHA) Functional Class III or IV
- Active Malignancy
- Human Immunodeficiency Virus infection on treatment with medications
- Treatment with steroids (medication related diabetes)
- Treatment with antipsychotics (medication related diabetes)
- Abnormal baseline Complete Blood Count
- Liver Function tests > 3 times upper limit of normal, Viral Hepatitis, or Elevated Liver Function tests of Unclear Etiology
- Currently participating in a supervised diet program through Department of Endocrinology
- Currently participating in any other research study, such as 15-1134: Prospective Validation of Predictive Tool study through Department of Endocrinology
- Treatment with Coumadin (warfarin)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Assessment of Diabetes Control, Cost of Care, and Quality of Life Utilizing a Functional Medicine Approach in Addition to Usual Care Vs. Usual Care Alone
A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the etiologies for "imbalances in the core physiological systems."(1) If underlying triggers and imbalances can be identified, the FM approach to addressing "root causes"(1) can be utilized through the use of specialized testing to treat and potentially reverse diabetes. If the FM approach is successful, the impact on diabetes disease burden as well as diabetes-associated health care costs could be significant. This project will assess the clinical as well as cost effectiveness of a FM approach to diabetes care compared to a usual care approach for patients with diabetes on insulin for 5 years or less.
Read the detailed description
This is a prospective, randomized, controlled, open-label clinical trial with a 1:1 randomization of patients with diabetes who have been on insulin less than 5 years to receive either Functional Medicine care in addition to usual care or to continue usual care delivered by an endocrinologist. The total number of patients planned for enrollment is 90, 45 in each arm. Patient recruitment will begin in the Cleveland Clinic main campus Endocrinology clinics and may later include Endocrinology practices at other Cleveland Clinic Health System sites.
Following voluntary informed consent, study subjects will complete a screening/baseline visit. After this visit, patients will be randomized to continuing usual care delivered by endocrinologists or to FM plus usual care. Once randomization occurs, the patient will continue to remain under the care of their endocrinologist and any other usual physicians. If randomized to the FM plus usual care group, subjects will receive additional care through a functional medicine physician.
A stratified randomization procedure will be used to allocate patients into the two groups according to the strata: Total Daily Insulin dose < = 50 units vs. > 50 units.
All subjects: In addition to usual care provided by the endocrinologist, study visits will occur at screening/baseline, 6 months, 12 months and 24 months. Lab data/Biometrics (if not recorded within 1 month time frame) will be obtained at this time. Quality of life instruments (Diabetes Distress Scale, SPADE, PHQ-9 and MSQ; Appendices D, E, F and G) will also be administered. At baseline, the 12 month visit, and the 24 month visit, a Body Fat Analysis by Bioelectrical impedance analysis (BIA) will be performed. There will also be 10 cc of blood collected for plasma and serum samples as well as 10 cc of urine and approximately 1 gram of stool for the bio repository if patient agrees to provide the samples.
Usual care subjects only: Subjects randomized to the usual care arm will receive a nutritional education session.
FM plus usual care subjects only: Subjects randomized to the FM plus usual care arm will be evaluated using the functional medicine approach to diabetes outlined in the Functional Medicine Diagnostic and Treatment Approach to Type 2 Diabetes Mellitus and Cardio-Metabolic Syndrome. Subjects randomized to the FM plus usual care arm will also receive nutrition therapy and dietary supplements. These will be prescribed and monitored at all Functional Medicine study visits. An estimated total of 50ml of blood will be collected from those subjects in this arm of the study at each designated visit. In addition, subjects may be asked to provide a urine and stool sample. Functional Medicine labs will be used in part to determine which supplements will be recommended.
- Being tested
- Functional Medicine
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MedicineDietary supplement
Subjects randomized to the Functional Medicine plus the usual care arm will receive nutrition therapy and dietary supplements. Functional Medicine labs will be used in part to determine which supplements will be prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | usual care delivered by an endocrinologist |
| Functional Medicine + Usual Care | Active comparator | Functional Medicine in addition to usual care delivered by an endocrinologist Receives: Dietary Supplement: Functional Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c
Discontinuation of insulin-no increase in Hemoglobin A1c-6 months
Measured: Baseline to 6 months
Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c
Discontinuation of insulin-no increase in Hemoglobin A1c-12 months
Measured: Baseline to 12 months
Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%
Discontinuation of insulin-Hemoglobin A1c <7%-6 months
Measured: Baseline to 6 months
Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%
Discontinuation of insulin-Hemoglobin A1c <7%-12 months
Measured: Baseline to 12 months
Secondary outcomes (28)
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Reduction in insulin use-no increase in Hemoglobin A1c-6 months
Measured: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Reduction in insulin use-no increase in Hemoglobin A1c-12 months
Measured: Baseline to 12 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Reduction in insulin use-Hemoglobin A1c <7%-6 months
Measured: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Reduction in insulin use-Hemoglobin A1c <7%-12 months
Measured: Baseline to 12 months
Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c
Reduction in number of insulin units-no increase in Hemoglobin A1c-6 months
Measured: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c
Reduction in number of insulin units-no increase in Hemoglobin A1c-12 months
Measured: Baseline to 12 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Reduction in number of insulin units-Hemoglobin A1c <7%-6 months
Measured: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Reduction in number of insulin units-Hemoglobin A1c <7%-12 months
Measured: Baseline to 12 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Evaluate diabetes control using subject hemoglobin A1c values-6 months
Measured: Baseline to 6 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Evaluate diabetes control using subject hemoglobin A1c values-12 months
Measured: Baseline to 12 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using Low density lipoprotein values-6 months
Measured: Baseline to 6 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using Low density lipoprotein values-12 months
Measured: Baseline to 12 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using High density lipoprotein (HDL)-6 months
Measured: Baseline to 6 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using High density lipoprotein (HDL)-12 months
Measured: Baseline to 12 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Evaluate cardiovascular risk factor using systolic blood pressure-6 months
Measured: Baseline to 6 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Evaluate cardiovascular risk factor using systolic blood pressure-6 months
Measured: Baseline to 12 months
Change in body weight (kg) for subjects in each study arm
Evaluate cardiovascular risk factor using Body weight-6 months
Measured: Baseline to 6 months
Change in body weight (kg) for subjects in each study arm
Evaluate cardiovascular risk factor using Body weight-12 months
Measured: Baseline to 12 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Evaluate the frequency of hypoglycemia-6 months
Measured: Baseline to 6 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Evaluate the frequency of hypoglycemia-12 months
Measured: Baseline to 12 months
Cost (dollars) of health care for subjects in each study arm
Cost of office visits, emergency room visits, hospital admissions, medication costs
Measured: Baseline to 12 months
Reduction in the total number of medications required for subjects in each study arm
Reduction in medication requirements
Measured: Baseline to 12 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Evaluate quality of life ratings using the Diabetes Distress Scale-6 months
Measured: Baseline to 6 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Evaluate quality of life ratings using the Diabetes Distress Scale-12 months
Measured: Baseline to 12 months
Change in the subject's T-Score on the SPADE survey in each study arm
Evaluate quality of life ratings using the general quality of life instrument (SPADE)-6 months
Measured: Baseline to 6 months
Change in the subject's T-Score on the SPADE survey in each study arm
Evaluate quality of life ratings using the general quality of life instrument (SPADE)-12 months
Measured: Baseline to 12 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Evaluate quality of life ratings using the Medical Symptom Questionnaire (MSQ)-6 months
Measured: Baseline to 6 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Evaluate quality of life ratings using the Medical Symptom Questionnaire (MSQ)-12 months
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start5 Mar 2017
- Primary completion1 Sep 2023
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between the functional medicine (FM) group and the usual care group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keren Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Keren Zhou, The Cleveland Clinic
- Investigators
- Betul Hatipoglu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070106
- Sponsor's protocol ID
- 16-1339
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2017
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Diabetes Control, Cost of Care, and Quality of Life Utilizing a Functional Medicine Approach in Addition to Usual Care Vs. Usual Care Alone
- ClinicalTrials.gov ID
- NCT03070106
- Acronym / sponsor ID
- 16-1339
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Keren ZhouUniversity, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Mar 2017 (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.
A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the etiologies for "imbalances in the core physiological systems."(1) If underlying triggers and imbalances can be identified, the FM approach to addressing "root causes"(1) can be utilized through the use of specialized testing to treat and potentially reverse diabetes. If the FM approach is successful, the impact on diabetes disease burden as well as diabetes-associated health care costs could be significant. This project will assess the clinical as well as cost effectiveness of a FM approach to diabetes care compared to a usual care approach for patients with diabetes on insulin for 5 years or less.
Detailed description
This is a prospective, randomized, controlled, open-label clinical trial with a 1:1 randomization of patients with diabetes who have been on insulin less than 5 years to receive either Functional Medicine care in addition to usual care or to continue usual care delivered by an endocrinologist. The total number of patients planned for enrollment is 90, 45 in each arm. Patient recruitment will begin in the Cleveland Clinic main campus Endocrinology clinics and may later include Endocrinology practices at other Cleveland Clinic Health System sites.
Following voluntary informed consent, study subjects will complete a screening/baseline visit. After this visit, patients will be randomized to continuing usual care delivered by endocrinologists or to FM plus usual care. Once randomization occurs, the patient will continue to remain under the care of their endocrinologist and any other usual physicians. If randomized to the FM plus usual care group, subjects will receive additional care through a functional medicine physician.
A stratified randomization procedure will be used to allocate patients into the two groups according to the strata: Total Daily Insulin dose < = 50 units vs. > 50 units.
All subjects: In addition to usual care provided by the endocrinologist, study visits will occur at screening/baseline, 6 months, 12 months and 24 months. Lab data/Biometrics (if not recorded within 1 month time frame) will be obtained at this time. Quality of life instruments (Diabetes Distress Scale, SPADE, PHQ-9 and MSQ; Appendices D, E, F and G) will also be administered. At baseline, the 12 month visit, and the 24 month visit, a Body Fat Analysis by Bioelectrical impedance analysis (BIA) will be performed. There will also be 10 cc of blood collected for plasma and serum samples as well as 10 cc of urine and approximately 1 gram of stool for the bio repository if patient agrees to provide the samples.
Usual care subjects only: Subjects randomized to the usual care arm will receive a nutritional education session.
FM plus usual care subjects only: Subjects randomized to the FM plus usual care arm will be evaluated using the functional medicine approach to diabetes outlined in the Functional Medicine Diagnostic and Treatment Approach to Type 2 Diabetes Mellitus and Cardio-Metabolic Syndrome. Subjects randomized to the FM plus usual care arm will also receive nutrition therapy and dietary supplements. These will be prescribed and monitored at all Functional Medicine study visits. An estimated total of 50ml of blood will be collected from those subjects in this arm of the study at each designated visit. In addition, subjects may be asked to provide a urine and stool sample. Functional Medicine labs will be used in part to determine which supplements will be recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between the functional medicine (FM) group and the usual care group
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –usual care delivered by an endocrinologist |
| Functional Medicine + Usual Care | Active comparator | Dietary Supplement: Functional MedicineFunctional Medicine in addition to usual care delivered by an endocrinologist |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Seen in the Cleveland Clinic Main Campus Endocrinology Clinics
- Diagnosis of Type 2 Diabetes
- Insulin treatment for at least 12 months, but for less than 96 months
- Total Daily Insulin Dose <= 150 units
Key exclusion criteria (19 listed)
- Positive glutamate decarboxylase antibody
- C peptide < 0.8 ng/ml
- Use of Insulin Pump for diabetes treatment
- HbA1c > 12%
- History of Diabetic Ketoacidosis (DKA) defined by patient report or any emergency department visits or hospitalization for DKA
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 |
|---|---|---|
| Functional MedicineSubjects randomized to the Functional Medicine plus the usual care arm will receive nutrition therapy and dietary supplements. Functional Medicine labs will be used in part to determine which supplements will be prescribed. | Dietary supplement | Functional Medicine + Usual Care |
Primary outcome
Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c
Time frame: Baseline to 6 months
Discontinuation of insulin-no increase in Hemoglobin A1c-6 months
Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c
Time frame: Baseline to 12 months
Discontinuation of insulin-no increase in Hemoglobin A1c-12 months
Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%
Time frame: Baseline to 6 months
Discontinuation of insulin-Hemoglobin A1c <7%-6 months
Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%
Time frame: Baseline to 12 months
Discontinuation of insulin-Hemoglobin A1c <7%-12 months
28 secondary outcomes
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Time frame: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Time frame: Baseline to 12 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Time frame: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Time frame: Baseline to 12 months
Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c
Time frame: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c
Time frame: Baseline to 12 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Time frame: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Time frame: Baseline to 12 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Time frame: Baseline to 6 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Time frame: Baseline to 12 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Time frame: Baseline to 6 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Time frame: Baseline to 12 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Time frame: Baseline to 6 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Time frame: Baseline to 12 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Time frame: Baseline to 6 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Time frame: Baseline to 12 months
Change in body weight (kg) for subjects in each study arm
Time frame: Baseline to 6 months
Change in body weight (kg) for subjects in each study arm
Time frame: Baseline to 12 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Time frame: Baseline to 6 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Time frame: Baseline to 12 months
Cost (dollars) of health care for subjects in each study arm
Time frame: Baseline to 12 months
Reduction in the total number of medications required for subjects in each study arm
Time frame: Baseline to 12 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Time frame: Baseline to 6 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Time frame: Baseline to 12 months
Change in the subject's T-Score on the SPADE survey in each study arm
Time frame: Baseline to 6 months
Change in the subject's T-Score on the SPADE survey in each study arm
Time frame: Baseline to 12 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Time frame: Baseline to 6 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Time frame: Baseline to 12 months
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 21 Mar 2025.
- 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.
Betul Hatipoglu, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Medicine in people with Diabetes and Type 2 Diabetes, run by Keren Zhou at 1 site in United States.
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 19 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 21 Mar 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 United States. 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?
Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c (time frame: Baseline to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2025.