Treatment for Metabolic Syndrome

1
Effectiveness
2
Safety
New Jersey Institute for Food, Nutrition & Health, New Brunswick, NJ
Metabolic Syndrome+4 More
Eligibility
18+
All Sexes
Eligible conditions
Metabolic Syndrome

Study Summary

This study is evaluating whether a combination of exercise and medication may help improve blood flow in the body.

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Eligible Conditions

  • Metabolic Syndrome
  • Insulin Resistance
  • Syndrome
  • Vascular Stiffness
  • Insulin Sensitivity

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Metabolic Syndrome. Measurement will happen over the course of At 0 and 16 weeks.

Week 16
Change in Ambulatory Blood Pressure
Change in Augmentation Index
Change in Contrast Enhanced Ultrasound
Change in Flow Mediated Dilation of Brachial Artery
Change in Metabolic Insulin Sensitivity by the Euglycemic Clamp
Change in Pulse Wave Velocity
Changes in Post Ischemic Flow Velocity in Brachial Artery

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

4 Treatment Groups

LoEx+Placebo
Placebo group

This trial requires 80 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment 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 2 & 3 and have had some early promising results.

LoEx+PlaceboSubjects will participate in 3 supervised training sessions and 2 unsupervised training sessions while receiving placebo. Drug: Low Intensity Exercise + Placebo Low Intensity Exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo.
LoEx+MetforminSubjects randomly assigned to this group will participate in the same 3 supervised training sessions and 2 unsupervised training sessions, but they will be provided Metformin. Metformin is a common medication routinely used to treat high blood sugar and has secondary effects on vascular health. Subjects will not find out whether or not they are on Metformin until after the study is complete. If their doctor needs to know, the people doing this study can find out. Drug: Low Intensity Exercise + Metformin Low Intensity Exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo.
HiEx+MetforminSubjects randomly assigned to this group will participate in the same HiEx 3 supervised training sessions and 2 unsupervised training sessions, but they will be provided Metformin. Drug: High Intensity Exercise + Metformin High Intensity Exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.
HiEx+PlaceboSubjects will participate in 3 supervised training sessions and 2 unsupervised training sessions while receiving placebo. Drug: High Intensity Exercise + Placebo High Intensity Exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 0 and 16 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 0 and 16 weeks for reporting.

Who is running the study

Principal Investigator
S. K. M.
Prof. Steven K Malin, PhD
Rutgers, The State University of New Jersey

Closest Location

New Jersey Institute for Food, Nutrition & Health - New Brunswick, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects currently taking medications that affect heart rate and rhythm (i.e. calcium-channel blockers, nitrates, alpha- or beta-blockers)
Not diagnosed with Type 2 diabetes
Not currently engaged in > 60 min/wk of exercise
Male or female ≥ 40 and ≤ 80 years old
Has a body mass index ≥ 27 and ≤ 47 kg/m^2
Increased waist circumference (≥ 102 cm in men; ≥ 88 cm in women)
Elevated triglycerides (≥ 150 mg/dl), or on medication for treating the condition
Reduced HDL-cholesterol (< 40 mg/dl in men, < 50 mg/dl in women), or on medication for treating the condition
High blood pressure (≥ 130 mmHg systolic or ≥ 85 mmHg diastolic), or on medication for treating the condition
Elevated fasting glucose (≥ 100 mg/dl), or on medication for treating the condition

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 is metabolic syndrome?

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Metabolic syndrome, a syndrome characterized by the presence of three or more of the following criteria (high blood pressure, high triglyceride level, high HDL-cholesterol level, and low HDL-cholesterol level), may be an early stage of type 2 diabetes.

Unverified Answer

Have there been any new discoveries for treating metabolic syndrome?

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The knowledge surrounding MetS has only begun to broaden. There is great potential for drug discovery to treat MetS, but with careful consideration and testing, the future may lead us to a new MetS therapy.

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What are common treatments for metabolic syndrome?

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Some treatments of metabolic syndrome are common and might be helpful to physicians, like exercise, smoking cessation, and dietary modifications. The treatments of the metabolic syndrome are complex and individualized, and the treatment should be based on the history, physical examination, lab tests, and lifestyle changes.

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What causes metabolic syndrome?

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A new understanding of the metabolic syndrome is emerging. Metabolic syndrome is a result of alterations in cellular lipid metabolism and insulin sensitivity. In this review the metabolic syndrome is presented as a complex disease caused by alterations that result in insulin resistance and decreased insulin sensitivity, with excess triglyceride and decreased β-hydroxy-β-methylbutyrate. The metabolic syndrome is caused by changes in the balance between energy and nutrient use. Obesity is the primary risk factor for the metabolic syndrome, but only accounts for a small proportion of the total risk. The metabolic syndrome can be prevented through reduction of high fat and saturated fat intake, and greater physical activity. Preventing metabolic syndrome will result in fewer cases of diabetes and heart diseases and stroke.

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Can metabolic syndrome be cured?

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Metabolic syndrome is strongly correlated with central obesity, hyperglycemia, cholesterol level as well as inflammation and high levels of hs-CRP and IL-6 in the blood. It was more strongly correlated with serum TGs level suggesting that hyperglycemia may play a fundamental role in the occurrence of metabolic syndrome. However, dietary therapy was ineffective to reduce the levels of HOMA-IR index and hs-CRP in patients with MetS at all sites or treatment intensity.

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What are the signs of metabolic syndrome?

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Patients with metabolic syndrome experience a range of symptoms. Weight gain in an otherwise healthy population is not a sign of metabolic syndrome. The features of the syndrome, however, include obesity, glucose intolerance, the clustering of metabolic risk factors, increased insulin resistance, increased adiposity and increased blood pressure. If patients present with those features, they are most likely to have metabolic syndrome. The diagnosis may be made more reliably by measurement of fasting glucose or a 75-g oesophagogastroduodenoscopy with blood glucose.

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

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The American Heart Association currently lists the metabolic syndrome for the first time in a comprehensive fashion. This was based on the results from National Survey of Health, Nutrition and Nutrition Status in America (NSHAN). Results from a recent clinical trial show that the prevalence of the metabolic syndrome is 10.2% for men and 9.3% for women ages 20 and older.

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Is treatment safe for people?

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This preliminary study suggests that the safety profile of the agents tested is comparable to that of placebo. Further long-term studies are required to quantify the safety profile, and the optimal timing and duration of treatment in patients with this disease.

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What is treatment?

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The current practice of offering patients clinical trial treatment options would be difficult for medical providers who are not the patients. Patients would want to know more about treatment options, but many would feel uncomfortable making decisions in a clinical care setting.

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

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The findings of this study suggest that patients with MS have significantly worse quality of life than matched patients without MS. Treatment with metformin was significantly associated with a more favourable QOL, particularly among men.

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Have there been other clinical trials involving treatment?

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Because of the small number of the studies done in DM and because most of the studies failed to meet their primary endpoint, more ongoing and larger studies are needed.

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What is the average age someone gets metabolic syndrome?

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Women were more likely to develop the syndrome than men. Body mass index was not related to development; however, aging accelerated development of the syndrome by 5 years.

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