Diabetes Mellitus, Type 2NCT04817514
"Shoulder Musculoskeletal Disorders in Type 2 Diabetes Mellitus: Contributing Factors and Rehabilitation Protocol"
A study testing Shoulder rehabilitation exercises and aerobic exercises in people with Diabetes Mellitus, Type 2 and Musculoskeletal Pain, run by Universidad Católica del Maule.
Trial summary
Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Musculoskeletal Pain, Shoulder Pain
- What is being tested?
- Shoulder rehabilitation exercises and aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Oct 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria will be participants with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 30 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity (PI-NRS).
Who cannot join
- It will be excluded participants with a history of stabilization or surgical shoulder repair; recent history of fracture of the upper limb; cognitive deficits that make it difficult to understand verbal commands; who have undergone shoulder rehabilitation in the past 6 months; neuromuscular diseases; central nervous system diseases and rheumatological arthropathies.
About this study
Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2 DM after 12 weeks of intervention and a subsequent follow up of 8 weeks. The secondary objective of this study will be to evaluate the association between AGEs accumulation and shoulder pain, function, strength, kinematics and tendon thickness in individuals with type 2 DM.
Methodology: is a single-blinded randomized controlled trial, in which all subjects with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 40 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity, will be invited to participate. The main outcomes of this study will include the AGEs accumulation through skin autofluorescence measurement; shoulder pain through NRS scales; shoulder function through SPADI questionnaire and range of motion measurement; isometric shoulder muscles strength through manual muscle dynamometer measurement; shoulder kinematics through three dimensional inertial units measurements; supraspinatus tendon thickness through ultrasound measurement. All these outcomes will be measured before and after the rehabilitation protocols. Participants will be randomly assigned to one of the two rehabilitation groups: specific shoulder rehabilitation protocol group (SRG); or 2) specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG). All individuals will be evaluated before starting the rehabilitation protocol (baseline) and at the end of rehabilitation (post 12 weeks) and 8 weeks after the end of the rehabilitation (follow up). For the statistical analysis, to verify the effectiveness of protocols over time, a variance analysis (ANOVA) of mixed model with Bonferroni adjustment will be performed for pairwise comparisons. Variables that do not meet the ANOVA assumptions will be analyzed by the Mann-Whitney and Wilcoxon tests with Bonferroni correction a priori. In order to assess the secondary objective of the study, correlation tests depending on data distribution will be performed (Pearson or Spearman correlation tests). A simple linear regression analysis will also be performed in order to analyze how much the AGEs accumulation can explain the alterations in the musculoskeletal and biomechanical variables. The significance level will be set at 5%.
Read the detailed description
SRG Protocol: shoulder rehabilitation protocol The protocol will be performed on a group with a maximum of 5 participants. Exercises intensity and difficulty will progress after completing 1 month of assistance, by increasing range of motion and loads (dumbbells) or resistance (elastic bands) in the exercises that are convenient. Each session will consist of 6 stages: 1) Pendulum exercise (10 repetitions - maintenance for 20 seconds); 2) Slide in flexion of the arms on the table (2 sets of 10 repetitions, maintenance in maximum range for 20 seconds); 3) Abduction and adduction (2 sets of 10 repetitions, maintenance for 20 seconds); 4) Wall slide - sliding of the arms on the wall (2 series of 10 repetitions, maintenance of 20 seconds); 5) Internal and external rotation (2 sets of 10 repetitions, maintenance for 20 seconds); 6) Elongation of the posterior capsule (cross-body) and pectoralis minor (3 repetitions of 30 seconds each). Pain will be evaluated during the protocol using the visual analog scale (VAS). The exercises proposed in this protocol are those that have already demonstrated in the literature an improvement in the function, strength, range of motion, and pain of the shoulder complex of the general population (27, 58).
The intensity and duration of the resistance exercises will be monitored by the physical therapist using heart rate monitors and adjusted to follow the same heart rate progression as outlined below for the aerobic group (ARG). In this manner, the average energy expenditure for both exercise groups will be similar. The protocol duration will be between 30-35 minutes. All sessions will be supervised by a physiotherapist with experience in physical exercise.
ARG group: Shoulder rehabilitation protocol combined to aerobic exercise program The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program. The aerobic program will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines (59). The program will be carried out in groups of 4 participants and each session will consist of 3 stages: 1) Warm-up (5 min): patients will perform stretches of the main muscle groups; 2) Aerobic exercise in the treadmill with continuous heart rate monitors (Polar Electro Oy, Kempele, Finland), which will be used to adjust workload to achieve the target heart rate (15-40 min); 3) Cooldown (5 min): Stretching of the main muscle groups worked during the sessions and relaxation. In this way, the rehabilitation protocol of ARG group will last a total of approximately 90 minutes maximum. Before and after each session, blood pressure, heart rate and subjective perception of effort will be measured. During sessions, heart rate will be monitored by a heart rate monitor (Polar Vantage, Finland), and perceived exertion will be measured using the Borg CR20 scale, which should remain approximately between 11-13 (59). All sessions will be supervised by a physiotherapist with experience in physical exercise.
- Being tested
- Shoulder rehabilitation exercises and aerobic exercises
- Keywords
- Diabetes mellitus, Shoulder function
- Medical subject headings
- Diabetes Mellitus, Type 2, Musculoskeletal Pain, Shoulder Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder rehabilitation exercises and aerobic exercisesOther
SRG group: the group will only perform mobility and strengthening exercises involving the shoulder complex.
ARG group: The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program that will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| specific shoulder rehabilitation protocol group (SRG); | Experimental | Not described Receives: Other: Shoulder rehabilitation exercises and aerobic exercises |
| specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG) | Experimental | Not described Receives: Other: Shoulder rehabilitation exercises and aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c - Glycated hemoglobin
HbA1c (mmol/mol) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
Measured: 12-weeks
lipid profile
lipid profile (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
Measured: 12-weeks
fasting glucose
fasting glucose (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
Measured: 12-weeks
AGEs accumulation measurement
Skin autofluorescence (nm wavelength) is considered as a substitute variable of AGEs accumulation. To perform this measurement, the AGE Reader (DiagnOptics, Groningen, the Netherlands) will be used, which non-invasively assesses skin autofluorescence.
Measured: 12-weeks
Shoulder pain measurement
Shoulder pain will be evaluated through the numerical pain scale (Numerical Rating Scale 0 to 10, the higher the score, higher the pain).
Measured: 12-weeks
Shoulder function measurement SPADI
The participant must respond to the SPADI questionnaire (Shoulder Pain and Disability Index - Spanish validated version).The SPADI score can range from 0 % indicating no pain or disability, to 100 % indicating severe pain and total disability
Measured: 12-weeks
Shoulder function measurement Range of motion
the range of motion will be measured (in degrees) for all shoulder complex movements using a digital inclinometer (Acumar™, Lafayette Intrument Company, Lafayette, IN).
Measured: 12-weeks
Isometric shoulder muscles strength measurement
Isometric muscle strength of the shoulder muscles will be assessed (in Newton) using a hand held dynamometer (HHD) (Lafayette Instrument, Lafayette, IN).
Measured: 12-weeks
Shoulder three dimensional kinematics
Shoulder three-dimensional kinematics (in degrees) will be recorded (80 Hz) during arm elevation in the scapular plane and during a reaching over 90° functional task, using an inertial movement units system (IMU system) (MTW Awinda Xsens, Nexgen Ergonomics, Canada).
Measured: 12-weeks
Supraspinatus tendon thickness measurement
Ultrasonographic measurement for each participant's supraspinatus tendon thickness (millimeters) will be scanned by using a Lumify Ultrasound in conjunction with a 4-12 MHz linear transducer (Philips Medical System).
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Fernanda Assis Paes Habechian, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817514
- Sponsor's protocol ID
- 11200574
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Habechian FAP, Flores Quezada ME, Cools AM, Kjaer BH, Cuevas Cid RI, Zanca GG. Shoulder-specific rehabilitation combined with aerobic exercises versus solely shoulder-specific rehabilitation in patients with type 2 diabetes mellitus: study protocol for a randomized controlled superiority trial. Trials. 2022 Aug 17;23(1):678. doi: 10.1186/s13063-022-06647-5.
PubMed 35978380
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Shoulder Musculoskeletal Disorders in Type 2 Diabetes Mellitus: Contributing Factors and Rehabilitation Protocol"
- ClinicalTrials.gov ID
- NCT04817514
- Acronym / sponsor ID
- 11200574
- Keywords
- Diabetes mellitus, Shoulder function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 26 Mar 2021 (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.
Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2 DM after 12 weeks of intervention and a subsequent follow up of 8 weeks. The secondary objective of this study will be to evaluate the association between AGEs accumulation and shoulder pain, function, strength, kinematics and tendon thickness in individuals with type 2 DM.
Methodology: is a single-blinded randomized controlled trial, in which all subjects with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 40 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity, will be invited to participate. The main outcomes of this study will include the AGEs accumulation through skin autofluorescence measurement; shoulder pain through NRS scales; shoulder function through SPADI questionnaire and range of motion measurement; isometric shoulder muscles strength through manual muscle dynamometer measurement; shoulder kinematics through three dimensional inertial units measurements; supraspinatus tendon thickness through ultrasound measurement. All these outcomes will be measured before and after the rehabilitation protocols. Participants will be randomly assigned to one of the two rehabilitation groups: specific shoulder rehabilitation protocol group (SRG); or 2) specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG). All individuals will be evaluated before starting the rehabilitation protocol (baseline) and at the end of rehabilitation (post 12 weeks) and 8 weeks after the end of the rehabilitation (follow up). For the statistical analysis, to verify the effectiveness of protocols over time, a variance analysis (ANOVA) of mixed model with Bonferroni adjustment will be performed for pairwise comparisons. Variables that do not meet the ANOVA assumptions will be analyzed by the Mann-Whitney and Wilcoxon tests with Bonferroni correction a priori. In order to assess the secondary objective of the study, correlation tests depending on data distribution will be performed (Pearson or Spearman correlation tests). A simple linear regression analysis will also be performed in order to analyze how much the AGEs accumulation can explain the alterations in the musculoskeletal and biomechanical variables. The significance level will be set at 5%.
Detailed description
SRG Protocol: shoulder rehabilitation protocol The protocol will be performed on a group with a maximum of 5 participants. Exercises intensity and difficulty will progress after completing 1 month of assistance, by increasing range of motion and loads (dumbbells) or resistance (elastic bands) in the exercises that are convenient. Each session will consist of 6 stages: 1) Pendulum exercise (10 repetitions - maintenance for 20 seconds); 2) Slide in flexion of the arms on the table (2 sets of 10 repetitions, maintenance in maximum range for 20 seconds); 3) Abduction and adduction (2 sets of 10 repetitions, maintenance for 20 seconds); 4) Wall slide - sliding of the arms on the wall (2 series of 10 repetitions, maintenance of 20 seconds); 5) Internal and external rotation (2 sets of 10 repetitions, maintenance for 20 seconds); 6) Elongation of the posterior capsule (cross-body) and pectoralis minor (3 repetitions of 30 seconds each). Pain will be evaluated during the protocol using the visual analog scale (VAS). The exercises proposed in this protocol are those that have already demonstrated in the literature an improvement in the function, strength, range of motion, and pain of the shoulder complex of the general population (27, 58).
The intensity and duration of the resistance exercises will be monitored by the physical therapist using heart rate monitors and adjusted to follow the same heart rate progression as outlined below for the aerobic group (ARG). In this manner, the average energy expenditure for both exercise groups will be similar. The protocol duration will be between 30-35 minutes. All sessions will be supervised by a physiotherapist with experience in physical exercise.
ARG group: Shoulder rehabilitation protocol combined to aerobic exercise program The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program. The aerobic program will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines (59). The program will be carried out in groups of 4 participants and each session will consist of 3 stages: 1) Warm-up (5 min): patients will perform stretches of the main muscle groups; 2) Aerobic exercise in the treadmill with continuous heart rate monitors (Polar Electro Oy, Kempele, Finland), which will be used to adjust workload to achieve the target heart rate (15-40 min); 3) Cooldown (5 min): Stretching of the main muscle groups worked during the sessions and relaxation. In this way, the rehabilitation protocol of ARG group will last a total of approximately 90 minutes maximum. Before and after each session, blood pressure, heart rate and subjective perception of effort will be measured. During sessions, heart rate will be monitored by a heart rate monitor (Polar Vantage, Finland), and perceived exertion will be measured using the Borg CR20 scale, which should remain approximately between 11-13 (59). All sessions will be supervised by a physiotherapist with experience in physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| specific shoulder rehabilitation protocol group (SRG); | Experimental | Other: Shoulder rehabilitation exercises and aerobic exercises |
| specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG) | Experimental | Other: Shoulder rehabilitation exercises and aerobic exercises |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria will be participants with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 30 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity (PI-NRS).
Key exclusion criteria (1 listed)
- It will be excluded participants with a history of stabilization or surgical shoulder repair; recent history of fracture of the upper limb; cognitive deficits that make it difficult to understand verbal commands; who have undergone shoulder rehabilitation in the past 6 months; neuromuscular diseases; central nervous system diseases and rheumatological arthropathies.
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 |
|---|---|---|
| Shoulder rehabilitation exercises and aerobic exercisesSRG group: the group will only perform mobility and strengthening exercises involving the shoulder complex. ARG group: The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program that will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines. | Other | specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG), specific shoulder rehabilitation protocol group (SRG); |
Primary outcome
HbA1c - Glycated hemoglobin
Time frame: 12-weeks
HbA1c (mmol/mol) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
lipid profile
Time frame: 12-weeks
lipid profile (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
fasting glucose
Time frame: 12-weeks
fasting glucose (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.
AGEs accumulation measurement
Time frame: 12-weeks
Skin autofluorescence (nm wavelength) is considered as a substitute variable of AGEs accumulation. To perform this measurement, the AGE Reader (DiagnOptics, Groningen, the Netherlands) will be used, which non-invasively assesses skin autofluorescence.
Shoulder pain measurement
Time frame: 12-weeks
Shoulder pain will be evaluated through the numerical pain scale (Numerical Rating Scale 0 to 10, the higher the score, higher the pain).
Shoulder function measurement SPADI
Time frame: 12-weeks
The participant must respond to the SPADI questionnaire (Shoulder Pain and Disability Index - Spanish validated version).The SPADI score can range from 0 % indicating no pain or disability, to 100 % indicating severe pain and total disability
Shoulder function measurement Range of motion
Time frame: 12-weeks
the range of motion will be measured (in degrees) for all shoulder complex movements using a digital inclinometer (Acumar™, Lafayette Intrument Company, Lafayette, IN).
Isometric shoulder muscles strength measurement
Time frame: 12-weeks
Isometric muscle strength of the shoulder muscles will be assessed (in Newton) using a hand held dynamometer (HHD) (Lafayette Instrument, Lafayette, IN).
Shoulder three dimensional kinematics
Time frame: 12-weeks
Shoulder three-dimensional kinematics (in degrees) will be recorded (80 Hz) during arm elevation in the scapular plane and during a reaching over 90° functional task, using an inertial movement units system (IMU system) (MTW Awinda Xsens, Nexgen Ergonomics, Canada).
Supraspinatus tendon thickness measurement
Time frame: 12-weeks
Ultrasonographic measurement for each participant's supraspinatus tendon thickness (millimeters) will be scanned by using a Lumify Ultrasound in conjunction with a 4-12 MHz linear transducer (Philips Medical System).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 35978380Habechian FAP, Flores Quezada ME, Cools AM, Kjaer BH, Cuevas Cid RI, Zanca GG. Shoulder-specific rehabilitation combined with aerobic exercises versus solely shoulder-specific rehabilitation in patients with type 2 diabetes mellitus: study protocol for a randomized controlled superiority trial. Trials. 2022 Aug 17;23(1):678. doi: 10.1186/s13063-022-06647-5.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder rehabilitation exercises and aerobic exercises in people with Diabetes Mellitus, Type 2 and Musculoskeletal Pain, run by Universidad Católica del Maule.
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 1 inclusion and 1 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
HbA1c - Glycated hemoglobin (time frame: 12-weeks). The study lists 10 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 NCT04817514, 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 26 Mar 2021.