CLINICAL TRIAL

Metformin for Metabolic Syndrome

Locally Advanced
Metastatic
Newly Diagnosed
Recruiting · 18+ · Male · Montreal, Canada

This study is evaluating whether metformin is more effective than placebo in treating prostate cancer.

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About the trial for Metabolic Syndrome

Eligible Conditions
Prostatic Neoplasms · Metabolic Syndrome · Syndrome · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Metformin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Metformin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo Oral Tablet
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Side Effect Profile for Vildagliptin (LAF237)

Vildagliptin (LAF237)
Show all side effects
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
0%
Angina pectoris
Nasopharyngitis
13%
Hyperhidrosis
10%
Hunger
9%
Tremor
9%
Asthenia
8%
Hypoglycaemia
6%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
1%
Angina pectoris
0%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02002221) in the Vildagliptin (LAF237) ARM group. Side effects include: Nasopharyngitis with 13%, Hyperhidrosis with 10%, Hunger with 9%, Tremor with 9%, Asthenia with 8%.

Eligibility

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Metabolic Syndrome or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
(Neo-)Adjuvant therapy for localized prostate cancer that is planned continuously for at least 9 months; or Metastatic disease: or A rising PSA after prior curative intent surgical therapy (e.g., prostatectomy with or without adjuvant/ salvage radiotherapy). Since an absolute consensus for this value has not been established, if a rising PSA has been documented by at least two PSA values at least 2 weeks apart, the criteria for biochemical recurrence are deemed to have been met. Or
PSA ≥ 2ng/mL above their nadir if previously treated with definitive radiotherapy
Pathologically confirmed adenocarcinoma of the prostate
Serum testosterone > 5nmol/L (except for participants who have already started androgen deprivation therapy (within no more than 45 days of commencing study treatment)).
The choice of androgen deprivation therapy is at the investigators discretion but must include at minimum the use of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy. The addition of other hormonal agents (e.g., non-steroidal antiandrogens, abiraterone, enzalutamide, apalutamide) is allowed.
The androgen deprivation therapy undertaken can be intermittent or continuous, but the treatment intent must be declared prior to randomization.
Participant is able (e.g., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the participant ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the participant ineligible.
Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate.
Participant must be accessible for treatment and follow up. Participants registered on this trial must be treated and followed at the participating centre. Investigators must assure themselves that the participants registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
Protocol treatment is to begin within 7 working days of participant randomization.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, an average of 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion, an average of 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 3 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Metformin will improve 1 primary outcome, 10 secondary outcomes, and 19 other outcomes in patients with Metabolic Syndrome. Measurement will happen over the course of 9 months.

Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 9 months of study treatment
9 MONTHS
A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose. The prevalence of metabolic syndrome at 9 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.
9 MONTHS
Exercise behavior and sedentary behavior assessed at 12 months of follow-up.
12 MONTHS
Exercise/sedentary questionnaire will be administered at 12 months of follow-up. Analyses of covariance (ANCOVA) to explore the effects of the intervention on moderate exercise minutes, vigorous exercise minutes, combined moderate and vigorous exercise minutes, and sedentary behavior hours will be conducted. Chi-square analyses to examine the effects of the intervention on meeting the exercise guidelines will be done.
12 MONTHS
Mean BMI assessed at 12 months of follow-up.
12 MONTHS
Measurement of height and weight will be performed by a dedicated research nurse for this study that is blinded to the patient's treatment allocation.
12 MONTHS
Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 12 months of study treatment
12 MONTHS
A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose. The prevalence of metabolic syndrome at 12 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.
12 MONTHS
Treatment-related toxicity
18 MONTHS
Treatment related toxicity (NCI CTCAE 4.0) All men will be evaluated for toxicity from the time of their first oral dose of study medication. Toxicities will be graded using the current CTCAE version 4.0. The incidence of toxicities by arm will be summarized by type of adverse effect. A Fisher's Exact Test will be used to compare toxicities between the two arms.
18 MONTHS
Duration of time off-treatment in days
18 MONTHS
The median duration of time off-treatment (i.e. ADT) in days will be compared between study arms (in the subset of patients on intermittent ADT) using the student t-test.
18 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can metabolic syndrome be cured?

With good treatment, symptoms can be eliminated, and metabolic abnormalities can be practically eliminated. However, there is no guarantee that they will not come back. Obesity is the only important risk factor for MetS that is not completely curable.

Anonymous Patient Answer

How many people get metabolic syndrome a year in the United States?

The prevalence of MetS is high in the United States, even among those 30-34 year olds who are asymptomatic. The number of those affected by the MetS is not clear. To know which groups are at the greatest risk is indispensable to the development of preventive and therapeutic interventions.

Anonymous Patient Answer

What are common treatments for metabolic syndrome?

Clinicians should have a good understanding of the underlying causes of insulin resistance in a patient with metabolic syndrome to select the best treatment. Clinicians need to be aware that some people will be responsive to statin therapy. However, statins are not effective in all patients with the metabolic syndrome. For patients not benefiting from statins, ezetimibe therapy offers reasonable improvement in blood lipid levels. Weight loss is effective in improving the lipid profiles in patients with metabolic syndrome, but there is a high risk that dieting will be ineffective due to the high adherence rate to dieting in the metabolic syndrome patient cohort. Weight loss and a reduction in the waist-to-hip ratio are key variables for preventing metabolic syndrome.

Anonymous Patient Answer

What is metabolic syndrome?

Metabolic syndrome seems to be one of the common complications among the patients with Type 2 diabetes, and they can exhibit a series of cardiovascular diseases, such as stroke, myocardial infarction, peripheral arterial disease, and non-cardiac vascular disease, which seems to be related to insulin resistance.

Anonymous Patient Answer

What are the signs of metabolic syndrome?

Metabolic syndrome is diagnosed when three of the following five criteria are met: 1) waist circumference > or = 5 x the 95th percentile ; 2) fasting plasma glucose > or = 6.1 mmol/L ; 3) triglycerides > or = 2.7 mmol/L ; 4) HDL cholesterol < 1.0 mmol/L ; and 5) blood pressure > or = systolic 140 mmHg or diastolic 90 mmHg. There is no specific medical test that can predict the development of diabetes or cardiovascular disease (CVD). However, if the patient fulfills 3 of the following criteria during a 5- yr follow-up period, they have a greater than 10% incidence of diabetes and CVD.

Anonymous Patient Answer

What causes metabolic syndrome?

Most people with metabolic syndrome have an underlying disorder, even if their symptoms are limited. The symptoms of metabolic syndrome are often the result of underlying pathophysiology, but many people with symptoms of metabolic syndrome have normal biochemistry and imaging tests, and no identifiable underlying condition. When metabolic syndrome is associated with a specific underlying disorder the syndrome is said to have a 'genetical' or known pathophysiology.

Anonymous Patient Answer

How does metformin work?

These data underscore the need for further investigation of the impact of metformin on insulin resistance and the metabolic control of non-diabetic patients with MS.

Anonymous Patient Answer

Have there been other clinical trials involving metformin?

Recent findings of the present trial suggest that metformin does not appear to increase the risk of pregnancy loss at least in women without previous pregnancy loss on account of a previous gestational diabetes mellitus diagnosis. Further meta-analysis of prospective controlled trials is warranted to confirm these results.

Anonymous Patient Answer

What are the chances of developing metabolic syndrome?

The probability that someone with MetS develops a clinical heart attack or stroke during a 10-year period varies widely. Overall, MetS does not substantially increase the chance of these events.

Anonymous Patient Answer

What is the latest research for metabolic syndrome?

The latest research indicates that the metabolic syndrome and insulin resistance are related to the risks of developing various types of cancers, cardiovascular diseases, and mental illnesses. The metabolic syndrome also increases the risk of developing chronic kidney disease, and the risk of developing Alzheimer's disease.

Anonymous Patient Answer

Does metformin improve quality of life for those with metabolic syndrome?

Metformin, when started at a moderate dose, improves quality of life for people with overweight/obesity and metabolic syndrome. However, people with higher HbA1c levels may not benefit from metformin. Future studies should investigate whether a higher dose of metformin may be advisable for patients with low dietary intake (hypophagic patients).

Anonymous Patient Answer

How quickly does metabolic syndrome spread?

The prevalence of MetS in the entire study population began to increase from 2003 until 2006. Interestingly, there was no evidence that the prevalence changed significantly between 2006 and 2008, suggesting the persistence of the MetS. We also found that a higher percentage of MetS in 2009 was associated with poorer self-rated health, irrespective of whether the patient was currently receiving statin treatment.

Anonymous Patient Answer
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