CLINICAL TRIAL

Exercise for Diabetes Mellitus, Type 2

Waitlist Available · 18+ · Male · Orlando, FL

This study is evaluating whether exercise can help people with chronic pain.

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About the trial for Diabetes Mellitus, Type 2

Eligible Conditions
Type 2 Diabetes Mellitus · Diabetes Mellitus · Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 2 different treatments. Exercise is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Exercise
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~1010

Eligibility

This trial is for male patients aged 18 and older. 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:
Type 2 Diabetes Inclusion Criteria (Group 1)
Age 30 to 65 years.
Male
Hispanic or Non-Hispanic Caucasian
Type 2 diabetes determined by self-report or by a fasting glucose > 126mg/dl
POCT HbA1c result is 5.7-8.8
HbA1c between 6.0% and 8.5%, if a participant misses the screening HbA1c by a small margin (HbA1c ± 0.1%), the HbA1c can be repeated once.
Not involved in regular exercise program
Willing to exercise every day for the study period
If applicable, those currently taking anti-diabetic medication are taking metformin, a sulfonylurea, DPP IV inhibitor, alpha-glucosidase inhibitor, a meglitinide, colesevelam, cycloset or a SGLT2 inhibitor. Those taking 2 of these medications may proceed.
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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: Baseline
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Exercise will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Baseline.

Promoter methylation
BASELINE
The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in ATPmax.
BASELINE
Change in ATPmax
BASELINE AND 10 WEEKS
The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis (ATPmax) measured using 31P magnetic resonance spectroscopy (MRS).
BASELINE AND 10 WEEKS
Change in in vivo and in vitro mitochondrial function
BASELINE AND 10 WEEKS
The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function (ATPmax) in vivo and exercise mimetic-induced changes in mitochondrial function in vitro (maximal oxygen consumption of the human primary myotubes by the Oroboros® oxygraph).
BASELINE AND 10 WEEKS

Patient Q & A Section

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

What are common treatments for diabetes mellitus, type 2?

Many patients with diabetes mellitus, type 2, use glucose-lowering medications for their treatment. These drugs can be classified as thiazolidinediones (TZDs), sulfonylureas, glyburide, metformin, and insulin. The use of thiazolidinediones (TZDs) is the most recent development. There have been concerns that these TZDs have an increased risk for cardiovascular complications in diabetic patients. However, studies do not support these concerns. Other studies have failed to demonstrate any cardiovascular risks for thiazolidinedione use.

Anonymous Patient Answer

What causes diabetes mellitus, type 2?

There are a variety of reasons why an individual may develop DM2. It is important that clinicians are aware of these reasons when assessing patients with DM2 for the management of this disease.

Anonymous Patient Answer

What are the signs of diabetes mellitus, type 2?

All patients with glucose intolerance, even those without diabetes, might be regarded as having DM, regardless of the clinical data or blood glucose results. At present, DM, i.e. fasting plasma glucose ≥ 6.1 mmol/l, should be considered as a 'diagnosis of exclusion'. Other findings indicated that the diabetes patients without oral glucose tolerance test could have DM, i.e. prediabetes.

Anonymous Patient Answer

Can diabetes mellitus, type 2 be cured?

With modern medical treatment, many persons with diabetes type 2 have excellent long-term quality of life and normal glucose tolerance. The most important factor that predicts the treatment outcome is a good metabolic control at the time of diagnosis.

Anonymous Patient Answer

How many people get diabetes mellitus, type 2 a year in the United States?

Nearly 19 million Americans have diabetes mellitus, type 2 a year and nearly 25% of the U.S. population had diabetes mellitus, type 2 in 1997. Diabetes prevalence rates will surely be higher in the future.

Anonymous Patient Answer

What is diabetes mellitus, type 2?

Diabetes mellitus, type 2 (DM2) is a complex condition in which the pancreas fails to make the necessary insulin. DM2 is the most common form of diabetes, and with more than one half of US adults having uncontrolled blood glucose, DM2 is the ninth leading cause of death and accounts for 30% of the cardiovascular diseases in the USA. DM2 is characterized by long-term high blood glucose, which over time causes damage in many tissues, including the heart and peripheral blood vessels. In the USA, 25.1million people have DM2, and DM2 is the second leading cause of diabetes-related deaths.

Anonymous Patient Answer

What are the latest developments in exercise for therapeutic use?

The latest research suggests that it is possible to improve exercise for therapeutic use through the inclusion of aerobic and muscle-damaging activities. The inclusion of an additional component during exercise programmes, such as the inclusion of muscle strengthening and cardiorespiratory training, could also make exercise programmes more effective to improve functional recovery. A number of exercise options for persons with diabetes are available. However, further research is required.

Anonymous Patient Answer

What is the latest research for diabetes mellitus, type 2?

Current investigations indicate that there is a need to develop safer oral antidiabetic agents, and it might be possible to develop a novel class of synthetic oral antidiabetic compounds which could significantly reduce the complications associated with the use of oral antidiabetic drugs. However, it will be some time before all the drawbacks of conventional treatment can be remedied with the new agents.

Anonymous Patient Answer

Is exercise typically used in combination with any other treatments?

Many of the newly diagnosed patients used regular physical activity as an adjunct therapy with other medications. However, a sizeable percentage of patients used more specific exercise regimens such as endurance training. Patients who wish to use physical activity as a first-line therapy must discuss their medication regimen with their neurologist before engaging in the exercise program.

Anonymous Patient Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

There have been remarkable advances in the discovery of new drug targets. Even though many of these targets are not yet in clinical development, it is clear to us that we will be continuing with the pursuit of new targets.

Anonymous Patient Answer

What is the average age someone gets diabetes mellitus, type 2?

Diabetes can be diagnosed a very early age for people. The condition was discovered to the average person at age 22 before they even realized it. It was discovered even to men before they even realized that they too were the target. It is also most common in women before women even realized they were target or even knew that being male was not the norm. A diabetes mellitus type 2 diagnosis is a bit earlier for women - for women, diagnosis typically happens around the age of 37 or 38. Diabetes mellitus type 2 is mostly diagnosed late for men - most men have their blood sugar measured in their 40's, typically the average age is about 45 for men diagnosed with diabetes, and this includes the condition known as prediabetes.

Anonymous Patient Answer

What does exercise usually treat?

Exercise for the treatment of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) is not supported by evidence-based medicine. This article outlines one of the many hurdles surgeons and their patients have to overcome when trying to implement this avenue of treatment for the 2 common and debilitating conditions, diabetes and arthritis. In addition, the effects of exercise on diabetes and the metabolic and structural changes in the body as a result of exercise are illustrated.

Anonymous Patient Answer
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