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Research Studies

Leadership Sinai Centre for Diabetes

The Leadership Sinai Centre for Diabetes regularly conducts clinical trials, and we invite participants to join our studies. If you are considering becoming a participant, you can find more information on our what you should know about research studies page. 
 

We are currently recruiting participants for the following studies:
 

 

1. RESET IT

Research Studies

The Leadership Sinai Centre for Diabetes at Mount Sinai Hospital is currently welcoming participants into the RESET IT trial.

What are we studying?

Type 2 diabetes is a progressive disease.  In people with type 2 diabetes, the ability of the body to make its own insulin tends to deteriorate over time.  The medications currently used to treat diabetes do not stop this process.  As a result, blood sugar levels tend to increase over time.  Previous studies have suggested that taking injections of insulin for a few weeks may be able to protect the beta-cells in the body that produce insulin. This effect on beta cells has allowed people with type 2 diabetes to then temporarily maintain blood sugar levels for several months afterwards without any diabetes medication. However, this "remission" phase is ultimately temporary and wanes over time.

At Mount Sinai Hospital, we are currently conducting clinical trial that focus on trying to maintain this remission, thus potentially modifying the natural history of type 2 diabetes.

Principal Investigators: Dr. Ravi Retnakaran and Dr. Bernard Zinman.

If you are interested in participating in this study at Mt. Sinai Hospital in Toronto and:

  • have had type 2 diabetes for 0-5 years
  • take no medication for diabetes or take metformin only for diabetes
  • are between the ages of 30-80 years
  • are willing to come for 10 visits over 2 years

For more information please call Haysook at (416) 586-8778 or E-mail hchoi@mtsinai.on.ca

 

 

2. EASE-2

Research Studies

Phase III, randomized, double-blind, placebo controlled, parallel group, efficacy, safety & tolerability trial of once daily Empagliflozin as Adjunctive to InSulin ThErapy over 52 weeks in patients with T1DM.

EASE-2 is a multicenter trial aiming to recruit 720 participants internationally.

Purpose of the EASE-2 trial:

The EASE-2 Clinical Trial is looking at the safety & effectiveness of a new oral medication for treating type 1 diabetes to be taken in addition to insulin treatment. The medication, which helps to control blood sugar by increasing the amount lost in urine, might be a useful add-on therapy to help type 1 diabetes patients meet their blood sugar goals..

Eligibility:

  • Have Type 1 Diabetes
  • Are at least 18 years old
  • Are currently using multiple daily insulin injections or an insulin pump

Length of Study:

The study will last for 64 weeks, during which time you will see the Study Doctor and/or nurse about 17 times for a total of 20 hours.
Insulin therapy will be optimised and if eligible, participants will be randomized to take either active study medication or placebo. Daily recording of diabetes management will be required on a smartphone which will be provided.

For more information please contact:

Nancy Cardinez [Study Coordinator & Co-Investigator]
Phone: (416) 586-4800 ext.4436, ncardinez@lunenfeld.ca
OR
Dr. Bruce Perkins

 

 

3. CONCEPTT

CONCEPTT

Purpose of the CONCEPTT trial:

The standard treatment for women with type 1 diabetes who are pregnant or planning pregnancy is the balancing of insulin, food and activity.  Blood glucose monitoring is used to guide therapy. Dr. Denice Feig at Mount Sinai Hospital is conducting a trial evaluating the benefit of adding a real-time continuous glucose monitoring (CGM) sensor to the standard therapy.

What are Continuous Glucose Monitoring Systems?

Continuous glucose monitoring systems measure the glucose levels in patients every five minutes and provide a graph of the trends of the blood sugars to help patients manage their diabetes.

What is the CONCEPTT trial?

This study is a randomized, open-label controlled trial funded by the Juvenile Diabetes Research Foundation that is randomizing women who are pregnant or planning pregnancy to either receive the CGM sensor added to standard therapy or standard therapy alone.  Click here for more information.
 

Entry Criteria:

  • Type 1 diabetes
  • Early in pregnancy or planning pregnancy
  • Age 18-40

Time commitment:

Study visits will be planned at the same time as your regular diabetes in pregnancy appointments.

For more information please contact:

Dr. Denice Feig

Mount Sinai Hospital

Phone: (416) 586-8590

 

Study Coordinator: Barbara Cleave

(416) 586-4800 x 2622

 

 

4. MiTy

MiTy

Purpose of the MiTy trial:

The standard treatment of women with type 2 diabetes in pregnancy is the use of insulin and diet. Our aim is to evaluate the benefit of adding metformin to the insulin that you are receiving already. We believe that adding metformin may help with blood sugar control, lower the dose of insulin needed, lower weight gain, and improve baby outcomes.

What is Metformin?

Metformin is a drug that has been used for many years to help patients manage type2 diabetes. Health Canada has approved the use of metformin in this trial. Metformin has been used in other trials in pregnant women. No harm has been found in these trials.

Although most women do not have any side effects, some side effects may include gastrointestinal discomfort, diarrhea, decreased appetite, and rarely metallic taste. These should not occur with a slow introduction of the medication.

What is the MiTy Trial?

The goal of this study is to compare the effect of taking insulin and metformin versus insulin and placebo (pills with no medicine in them). This study is a randomized, blinded controlled trial funded by the Canadian Institutes of Health Research. There is a 50/50 chance of being assigned to take metformin plus insulin or insulin and placebo. Neither you nor your caregiver will be told whether you are receiving metformin or the placebo.
 

Entry Criteria:

  • Type 2 Diabetes diagnosed prior to 20 weeks of pregnancy
  • 6-22 weeks pregnant
  • Age 18-45

Time commitment:

Study visits will be planned at the same time as your regular diabetes in pregnancy appointments.

For more information please contact:

Dr. Denice Feig

Mount Sinai Hospital

Phone: (416) 586-8590

 

Study Coordinator: Barbara Cleave

(416) 586-4800 x 2622

 

 

5. Do you have Type 2 Diabetes with circulation problems, heart disease, or kidney problems?

Dr. Bernard Zinman at the Leadership Sinai Centre for Diabetes is conducting research studies evaluating several diabetes medications in cardiovascular disease.

For more information and eligibility requirements please contact Stella skink@mtsinai.on.ca or Paula pvannostrand@mtsinai.on.ca or call 416-586-8775.

 

 

 

6. GAP Study

In this study, the levels of certain proteins or markers in the blood related to diabetes are being studied in both women with diabetes during pregnancy (gestational diabetes) and those without diabetes during pregnancy. Participants' markers and their relationships with blood sugar levels are then being assessed at roughly 3 months and 1 year after pregnancy.

So far, this study has shown that:

  1. One of the markers may be related to how well the body produces insulin (the substance made by the body to control blood sugar levels);
  2.  The production of insulin is influenced by how well the insulin works in the body;
  3. A woman’s ethnic background plays a role in how her weight affects the function of insulin during pregnancy;
  4. The timing of a single high value on the oral glucose tolerance test in pregnancy may be related to how well your body’s insulin works when you are pregnant.

This study is giving us important information into factors that may cause diabetes, a disease of epidemic proportions in our society.

If you’d like to read more about these results, you can find more information in the articles listed below.

1. Beta-cell function declines in first year post-partum -- Retnakaran et al. (2010)

2. Effect on materal weight on infant birth weight -- CMAJ Retnakaran et al. (2012)

3. Circadian variation in response to GCT -- Goldberg et al. (2012) 

 

 

7. PERL Study

PERL - Preventing Early Renal Loss in Diabetes

Do you have Type 1 diabetes and kidney problems?

We want to help.

Will you join us?

 

What does ‘PERL’ stand for?

Preventing Early Renal (=kidney) function Loss in Diabetes

 

What is the PERL study?

One of the goals of researchers at Leadership Sinai Diabetes Centre is to find new ways to prevent kidney disease in people with diabetes. In the PERL study we are using a medication called allopurinol to see whether it may help prevent the loss of kidney function that sometimes occurs in people with Type 1 diabetes. 

Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints.  There is some evidence suggesting that allopurinol might also be useful in people with diabetes who have normal kidney function or early to moderate kidney function loss by decreasing uric acid, therefore reducing the risk of developing kidney disease in the future. However, this beneficial effect must be proved by further studies.

To prove this beneficial effect of allopurinol, we are conducting an international clinical trial, together with other diabetes centers, enrolling approximately 480 patients in total. This study is funded by a research grant from the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation (JDRF). 

Am I eligible for this study?

To can be eligible for the study if you:

  • are between 18 and 65 years old
  • have type 1 diabetes for more than 8 years
  • were told by your physician that you have kidney damage as a result of your diabetes or told that you have had any amount of protein in your urine (such as microalbuminuria)

 

What to expect when I participate in the study?

The study involves 17 visits at our clinic, spread over about a 3 and ½ year period and taking four allopurinol or placebo capsules (inactive capsules that look like allopurinol), once a day during this time frame.

How can I take part or learn more about the study?

If you have interest in finding out more about participating in this study please call 416-586-4800 ext. 8138 (Marcelo) or send an email to perlstudy@lunenfeld.ca

Physician responsible for the study: Dr. Bruce Perkins

Learn more at: www.perl-study.org

 

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