ObesityPhase 2FMTNCT03727321
FMT and Fiber in Patients With Metabolic Syndrome
A Phase 2 study testing Fecal Microbial Transplant, Fiber and Cellulose in people with Obesity and Metabolic Syndrome, run by University of Alberta at 2 sites in Canada.
Trial summary
This study is looking at the safety and effectiveness of stool transplant, also known as Fecal Microbiota Transplantation (FMT) and prebiotic supplementation in the management of metabolic syndrome. Metabolic syndrome is a common progressive medical condition that is linked to obesity, diabetes, and heart disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Fecal Microbial Transplant, Fiber and Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2018to 16 Jan 2020
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥ 18 and < 65 years at the time of screening
- BMI > 30
- Total body weight fluctuation over the last 6 months less than 10%
- Fasting plasma glucose > 5.6 mmol/L OR HgbA1c ≥5.5% OR patients receiving an antidiabetic medication
- At least one of the following:
- Fasting triglyceride ≥1.7 mmol/L OR receiving dyslipidemia medication
- HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females OR receiving dyslipidemia medication
- Known diagnosis of hypertension OR systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg OR receiving antihypertension medication
Who cannot join
- • Systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg at screening.
- Triglyceride ≥6 mmol/L.
- Acute infectious or inflammatory condition over the presiding 4 weeks.
- Current or recent use (Previous 6 months) of insulin for diabetes control.
- History of oropharyngeal or significant esophageal dysphagia, inflammatory bowel disease, colon cancer, or colonic polyps with high grade dysplasia.
- History of autoimmune conditions or chronic inflammatory condition, such as rheumatoid arthritis, chronic active hepatitis B or C, HIV, chronic pancreatitis, advanced NASH, or liver cirrhosis.
- Active malignancy.
- Active substance abuse or excessive EtOH (defined as >2 X 8oz drinks/d).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
About this study
Official title: Fecal Microbial Transplantation and Fiber Supplementation in Subjects With Obesity and Metabolic Syndrome
This study is looking at the safety and effectiveness of stool transplant, also known as Fecal Microbiota Transplantation (FMT) and prebiotic supplementation in the management of metabolic syndrome.
Metabolic syndrome is a common progressive medical condition that is linked to obesity, diabetes, and heart disease. Obesity and metabolic syndrome are associated with abnormalities in gut flora which lead to chronic inflammation. This chronic inflammation is thought to worsen the insulin resistance and heart disease seen with metabolic syndrome. Current treatment strategies have shown limited effect, are expensive, and have side effects with long-term use.
Read more
FMT is a one-time treatment that has been shown to replace the abnormal gut flora and improve metabolic disease by increasing anti-inflammatory short chain fatty acid (SCFA) production. However, the effects from FMT are not permanent. Prebiotic supplementation is one strategy that may help to extend the benefits of FMT by helping sustain high SCFA levels. At this point, it is not known how FMT and prebiotics work together to affect SCFA levels in participants with metabolic syndrome.
This study will look at this interaction and answer if prebiotic therapy is effective in prolonging the benefits of FMT in participants with metabolic syndrome.
Read the detailed description
3.0 Design This is an exploratory four-arm, parallel design, randomized placebo-controlled intervention study in obese individuals with metabolic syndrome to evaluate whether FMT from lean donors combined with supplementation with prebiotic fiber will have a clinically significant effect on metabolic parameters. The study includes a 2-week screening/baseline period followed by a single FMT and a 6 week study period in which prebiotic fiber or placebo will be added in powdered form to the subject's normal diet for the duration of the trial (Appendix 1). A follow-up visit at 12 weeks will be done to determine if beneficial effects are maintained in the absence of ongoing fiber intake. A parallel arm design was chosen to avoid cross-over effects.
The four groups are:
- Control (Placebo FMT and cellulose)
- FMT only (FMT followed by cellulose)
- Prebiotic only (Placebo FMT and prebiotic fiber)
- FMT + prebiotic fiber Schedule and Procedures: Subjects will attend a total of 5 clinic appointments throughout the study for anthropometric and blood pressure measurements, dietary intake, hunger and satiety, and quality of life assessment using questionnaires, and for collection of blood and fecal samples (Appendix 2). The intervention will be stopped at 6 weeks. A final follow-up visit will occur at 12 weeks for anthropometric and blood pressure measurements, and collection of blood and stool samples.
3.1 Randomization Subjects will be randomized to one of 4 groups via computer-generated numbers and stratified by gender. Individuals will be blinded as to their group allocation to reduce bias. Randomization concealment will be protected by several levels of security, including our secure website, password protection by only those authorized to randomize and a variable blocked randomization.
3.2 Maintenance
Randomized codes will be maintained in REDCAP. Codes will be broken at the end of the trial.
3.3 Trial Treatment
Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth. These capsules will be frozen at -700C until date of administration on day 1 of the trial. The FMT will be given after individuals have fasted overnight and completes a bowel preparation using Pico-Salax®, a routine colonoscopy preparation. The study will use only one donor to reduce variability in donor profiles unless this donor becomes unavailable at which point backup donors will be available. Placebo FMT will consist of cellulose pills.
Fiber Supplementation:
Soluble corn fiber (PROMITOR®: Tate\&Lyle)
- Women: 4.5 gm of PROMITOR by mouth days 1-3 increased to 9 gm daily from day 4 until trial completion.
- Men: 5.5 gm of PROMITOR by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients):
- Women: 4.5 gm of powdered RS4 by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
- Men: 5.5gm of powdered RS4 by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS):
- Women: 4.5 gm of powdered acacia gum by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
- Men: 5.5gm of powdered acacia gum by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
The product will be supplied to patients on a weekly basis in pre-weighed foil packets.
Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in identical foil packets.
3.4 Duration
The study duration is 12 weeks. Subjects will be seen in the clinic at recruitment, and then at 2 and 6 weeks following FMT. Intervention will be from 1-6 weeks. A final follow-up visit will occur at 12 weeks (Appendix 1)
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Fecal Microbial Transplant, Fiber, Cellulose
- Keywords
- Fecal microbial transplant, obesity, metabolic syndrome
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantCombination product
Also called FMT
Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
FiberDietary supplement
A combination of soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), and Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS) for a total of 6 weeks (men 33g/day; women 27g/day)
CelluloseDietary supplement
Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets. Receives: Dietary Supplement: Cellulose |
| Fecal Microbial Transplant and cellulose | Experimental | 1. Fecal Microbial Transplant - Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
2. Cellulose x 6weeks Receives: Combination Product: Fecal Microbial Transplant; Dietary Supplement: Cellulose |
| Fiber | Experimental | Soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS). Receives: Dietary Supplement: Fiber |
| Fecal Microbial Transplant and Fiber | Experimental | 1. Fecal Microbial Transplant
2. Soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS). Receives: Combination Product: Fecal Microbial Transplant; Dietary Supplement: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity Assessment
The homeostasis Model Assessment-Insulin Resistance (HOMA-IR) is a mathematical model to predict the interaction between glucose and insulin dynamics across a range of glucose plasma levels assuming a feedback circuit between the liver and β-cells in the pancreas
Measured: 12 weeks
Secondary outcomes (9)
Health-related quality of life (HRQL): EQ-5D Index
Assessment of the current health related quality of life will be accomplished by conducting standardized interviews and by using the validated questionnaires EQ-5D Index. Participants will report perceived health outcomes using this validated survey, and rank overall perceived health from 0 (low)- 100 (high).
Measured: 12 week
Dietary Intake
Dietary intake will be assessed for each clinic using MyFitnessPal.
Measured: 12 week
Inflammatory markers
. Levels of leptin, ghrelin, adiponectin, TNFα, IL-6, LPS (lipopolysaccharide), LPS-binding protein and zonulin will be determined using currently accepted laboratory techniques.
Measured: 12 week
Stool Microbiome
Stool microbiome will be analyzed for Operational Taxonomic Unit determination.
Measured: 12 weeks
Anthropometric Measurements
BMI (kg/m2)
Measured: 12 weeks
Fasting lipid profile
Changes in Fasting lipid profile between baseline and 6 and 12 weeks
Measured: 12 weeks
Glucose Tolerance Assessment
The oral glucose tolerance test (OGTT) is a dynamic test that reflects the efficiency of the body to dispose of glucose after an oral load. It is commonly used in clinical scenarios to diagnose glucose intolerance and diabetes. [33] After overnight fast (> 8 h), blood samples for determination of glucose and insulin concentration will be taken at -5, 0, 30, 60, and 120 min following a standard oral glucose load.
Measured: 12 weeks
Hunger and Satiety Assessment
Assessed via the standardized hunger and satiety questionnaire (categorical variables with no analog scale)
Measured: 12 weeks
Gastrointestinal tolerance
Assessed via the standardized gastrointestinal tolerance questionnaire (categorical variables with no analog scale)
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 posted1 Nov 2018
- Study start1 Jul 2018
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- The Weston A. Price Foundation
- Responsible party
- Sponsor
- Investigators
- Karen Madsen, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727321
- Sponsor's protocol ID
- Pro00076642
- Acronym
- FMT
- Status last verified
- May 2020
- First submitted
- 24 Oct 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual participant data will be kept private and not distributed to other researchers outside of our study group. After the study is done, we will keep data stored for 25 years.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation and Fiber Supplementation in Subjects With Obesity and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03727321
- Acronym / sponsor ID
- FMT / Pro00076642
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Fecal microbial transplant, obesity, metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- The Weston A. Price Foundation
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 1 Nov 2018 (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.
This study is looking at the safety and effectiveness of stool transplant, also known as Fecal Microbiota Transplantation (FMT) and prebiotic supplementation in the management of metabolic syndrome.
Metabolic syndrome is a common progressive medical condition that is linked to obesity, diabetes, and heart disease. Obesity and metabolic syndrome are associated with abnormalities in gut flora which lead to chronic inflammation. This chronic inflammation is thought to worsen the insulin resistance and heart disease seen with metabolic syndrome. Current treatment strategies have shown limited effect, are expensive, and have side effects with long-term use.
FMT is a one-time treatment that has been shown to replace the abnormal gut flora and improve metabolic disease by increasing anti-inflammatory short chain fatty acid (SCFA) production. However, the effects from FMT are not permanent. Prebiotic supplementation is one strategy that may help to extend the benefits of FMT by helping sustain high SCFA levels. At this point, it is not known how FMT and prebiotics work together to affect SCFA levels in participants with metabolic syndrome.
This study will look at this interaction and answer if prebiotic therapy is effective in prolonging the benefits of FMT in participants with metabolic syndrome.
Detailed description
3.0 Design This is an exploratory four-arm, parallel design, randomized placebo-controlled intervention study in obese individuals with metabolic syndrome to evaluate whether FMT from lean donors combined with supplementation with prebiotic fiber will have a clinically significant effect on metabolic parameters. The study includes a 2-week screening/baseline period followed by a single FMT and a 6 week study period in which prebiotic fiber or placebo will be added in powdered form to the subject's normal diet for the duration of the trial (Appendix 1). A follow-up visit at 12 weeks will be done to determine if beneficial effects are maintained in the absence of ongoing fiber intake. A parallel arm design was chosen to avoid cross-over effects.
The four groups are:
- Control (Placebo FMT and cellulose)
- FMT only (FMT followed by cellulose)
- Prebiotic only (Placebo FMT and prebiotic fiber)
- FMT + prebiotic fiber Schedule and Procedures: Subjects will attend a total of 5 clinic appointments throughout the study for anthropometric and blood pressure measurements, dietary intake, hunger and satiety, and quality of life assessment using questionnaires, and for collection of blood and fecal samples (Appendix 2). The intervention will be stopped at 6 weeks. A final follow-up visit will occur at 12 weeks for anthropometric and blood pressure measurements, and collection of blood and stool samples.
3.1 Randomization Subjects will be randomized to one of 4 groups via computer-generated numbers and stratified by gender. Individuals will be blinded as to their group allocation to reduce bias. Randomization concealment will be protected by several levels of security, including our secure website, password protection by only those authorized to randomize and a variable blocked randomization.
3.2 Maintenance
Randomized codes will be maintained in REDCAP. Codes will be broken at the end of the trial.
3.3 Trial Treatment
Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth. These capsules will be frozen at -700C until date of administration on day 1 of the trial. The FMT will be given after individuals have fasted overnight and completes a bowel preparation using Pico-Salax®, a routine colonoscopy preparation. The study will use only one donor to reduce variability in donor profiles unless this donor becomes unavailable at which point backup donors will be available. Placebo FMT will consist of cellulose pills.
Fiber Supplementation:
Soluble corn fiber (PROMITOR®: Tate\&Lyle)
- Women: 4.5 gm of PROMITOR by mouth days 1-3 increased to 9 gm daily from day 4 until trial completion.
- Men: 5.5 gm of PROMITOR by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients):
- Women: 4.5 gm of powdered RS4 by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
- Men: 5.5gm of powdered RS4 by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS):
- Women: 4.5 gm of powdered acacia gum by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
- Men: 5.5gm of powdered acacia gum by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.
The product will be supplied to patients on a weekly basis in pre-weighed foil packets.
Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in identical foil packets.
3.4 Duration
The study duration is 12 weeks. Subjects will be seen in the clinic at recruitment, and then at 2 and 6 weeks following FMT. Intervention will be from 1-6 weeks. A final follow-up visit will occur at 12 weeks (Appendix 1)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: CellulosePlacebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets. |
| Fecal Microbial Transplant and cellulose | Experimental | Combination Product: Fecal Microbial Transplant, Dietary Supplement: Cellulose1. Fecal Microbial Transplant - Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth. 2. Cellulose x 6weeks |
| Fiber | Experimental | Dietary Supplement: FiberSoluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS). |
| Fecal Microbial Transplant and Fiber | Experimental | Combination Product: Fecal Microbial Transplant, Dietary Supplement: Fiber1. Fecal Microbial Transplant 2. Soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Age ≥ 18 and < 65 years at the time of screening
Key exclusion criteria (8 listed)
- • Systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg at screening.
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 |
|---|---|---|
| Fecal Microbial TransplantAlso: FMTFecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth. | Combination product | Fecal Microbial Transplant and Fiber, Fecal Microbial Transplant and cellulose |
| FiberA combination of soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), and Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS) for a total of 6 weeks (men 33g/day; women 27g/day) | Dietary supplement | Fecal Microbial Transplant and Fiber, Fiber |
| CellulosePlacebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets. | Dietary supplement | Fecal Microbial Transplant and cellulose, Placebo |
Primary outcome
Insulin Sensitivity Assessment
Time frame: 12 weeks
The homeostasis Model Assessment-Insulin Resistance (HOMA-IR) is a mathematical model to predict the interaction between glucose and insulin dynamics across a range of glucose plasma levels assuming a feedback circuit between the liver and β-cells in the pancreas
9 secondary outcomes
Health-related quality of life (HRQL): EQ-5D Index
Time frame: 12 week
Dietary Intake
Time frame: 12 week
Inflammatory markers
Time frame: 12 week
Stool Microbiome
Time frame: 12 weeks
Anthropometric Measurements
Time frame: 12 weeks
Fasting lipid profile
Time frame: 12 weeks
Glucose Tolerance Assessment
Time frame: 12 weeks
Hunger and Satiety Assessment
Time frame: 12 weeks
Gastrointestinal tolerance
Time frame: 12 weeks
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 5 May 2020.
- Individual participant dataSharing planned: No. All individual participant data will be kept private and not distributed to other researchers outside of our study group. After the study is done, we will keep data stored for 25 years.
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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.
Karen Madsen, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbial Transplant, Fiber and Cellulose in people with Obesity and Metabolic Syndrome, run by University of Alberta at 2 sites in Canada.
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 8 inclusion and 8 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin Sensitivity Assessment (time frame: 12 weeks). 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 5 May 2020.