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DyslipidemiasPhase 3NCT02030041

Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy

A Phase 3 study testing Vitamin D and Simvastatin in people with Dyslipidemias, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Statins along with lifestyle modifications including exercise are commonly prescribed to patients with type 2 diabetes. American diabetes association recommends using moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years, even without additional cardiovascular disease(CVD) risk… Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Dyslipidemias
What is being tested?
Vitamin D and Simvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteIndia
Study dates
Dec 2013to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Type 2 Diabetes Mellitus
  • No significant microvascular complication
  • Age between 25 and 50 yrs
  • HbA1c<7.5%
  • LDL-C between 100 to 130mg/dl
  • Overweight or obese (BMI 25 -39 kg/m2)
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  • Low physical activity(WHO-GPAQ)
  • Euthyroid , Eugonadal
  • Vitamin D deficient (<20 ng/ml)
  • Normal ECG

Who cannot join

  • Use of statins in past 3 months
  • Use of Thiazolidinediones, Glucagon like peptide -1agonists, Dipeptidyl Peptidase -IV inhibitors, steroids, orlistat or other medicines affecting lipid profile or body weight
  • Smoking
  • On Vitamin D supplementation
  • Uncontrolled DM with HbA1c>7.5
  • Uncontrolled hypertension
Show all 10Show fewer
  • Significant microvascular complication of DM
  • Macrovascular disease
  • Musculoskeletal problems resulting in inability to exercise
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

India1 site
  • PGIMER

    Chandigarh, Chandigarh, 160012

Other trials in India

About this study

Statins along with lifestyle modifications including exercise are commonly prescribed to patients with type 2 diabetes. American diabetes association recommends using moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years, even without additional cardiovascular disease(CVD) risk factors.. Myopathy is a well known adverse effect of statins, which occurs in 1-7% of patients. The spectrum of statin-related myopathy ranges from common benign myalgia to rare but life threatening rhabdomyolysis. Being lipophilic, simvastatin diffuses nonselectively into extrahepatic tissues such as muscle, leading to higher incidence of myopathy among statin users.

In addition, simvastatin attenuates the exercise-induced increase in cardiorespiratory fitness, and reduces the skeletal muscle mitochondrial content and oxidative capacity in humans. Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of adenosine triphosphate (ATP) during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.

Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression). Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. This study is being done to look for the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes

Read the detailed description

Statins, a class of hydroxyl methylglutaryl-coenzyme A reductase inhibitors that lower low-density lipoprotein cholesterol, are commonly prescribed to patients with the metabolic syndrome or those with multiple cardiovascular disease risk factors when lifestyle changes fail to achieve LDL targets to reduce the risk of coronary heart disease morbidity and mortality. American Diabetes Association (ADA) recommends moderate intensity statin for patients with diabetes without additional CVD risk factors aged >40.Statins are widely prescribed in combination with exercise to lower risk of cardiovascular disease morbidity and mortality. Every 1millimole per liter reduction in LDL is associated with a 10-20% reduction in risk of cardiovascular events and all-cause mortality, while every 1 Metabolic equivalent [MET] (3.5 milliliters of oxygen per kilogram of body weight per minute) increase in fitness is associated with an 18% reduction in cardiovascular disease mortality and an 11-50% reduction in all-cause mortality.Statins are generally safe, but myotoxicity, including fatal rhabdomyolysis can occur. Although severe muscle-related side effects occur in <0.1% of statin users, less severe symptoms, such as myalgia and muscle cramps, occur in 1-7% of users.

The mechanisms mediating statin myopathy are unclear, but possibilities include decreased sarcolemmal or endoplasmic reticulum cholesterol, reduced production of prenylated proteins including the mitochondrial electron transport protein coenzyme Q10, reduced fat catabolism, increased myocellular concentrations of cholesterol and plant sterols, failure to repair damaged skeletal muscle, vitamin D deficiency, and inflammation. Increasingly, interest has focused on altered cellular energy use and mitochondrial dysfunction, with the dysfunction activating pathways leading to muscle atrophy. Although the mechanisms are poorly understood, some statins (simvastatin, atorvastatin, fluvastatin) have been shown to reduce skeletal muscle mitochondrial content and oxidative capacity in humans.

Sirvent et al evaluated the mitochondrial function and calcium signaling in muscles of patients treated with statins, who present or not muscle symptoms, by oxygraphy and recording of calcium sparks, respectively. Patients treated with statins showed impairment of mitochondrial respiration that involved mainly the complex I of the respiratory chain and altered frequency and amplitude of calcium sparks. The muscle problems observed in statin-treated patients appear thus to be related to impairment of mitochondrial function and muscle calcium homeostasis.

Mikus et al examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity). Thirty-seven participants (exercise plus statins; n=18; exercise only; n=19) completed the study. Cardiorespiratory fitness increased by 10% (P<0.05) in response to exercise training alone, but was blunted by the addition of simvastatin resulting in only a 1.5% increase (P<0.005 for group by time interaction). Similarly, skeletal muscle citrate synthase activity increased by 13% in the exercise only group (P <0.05), but decreased by 4.5% in the simvastatin plus exercise group (P<0.05 ) Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of ATP during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.

Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression).

Mukherjee et al conducted a study in which chicks were raised for 3 to 4 weeks either on a normal (vitamin D supplemented) or a rachitogenic diet. The Ca2+ content of the serum, heart tissue and heart mitochondria was significantly decreased in chicks raised on a rachitogenic diet. In mitochondria isolated from calcium deficient hearts, the rate of adenosine diphosphate induced state 3 respiration and 2,4-Dinitrophenol uncoupled respiration were significantly decreased.When vitamin D deficient chicks were orally dosed with vitamin D3, serum calcium level and state 3 respiration rate returned to normal indicating that the above changes are reversible In a longitudinal study, the effects of cholecalciferol therapy on skeletal mitochondrial oxidative function in vitamin D deficient subjects using 31Phosphorus magnetic resonance spectroscopy were examined.The phosphocreatine recovery half-time (t1/2PCr) was significantly reduced after cholecalciferol therapy in the subjects indicating an improvement in maximal oxidative phosphorylation (34.44 ±8.18 sec to 27.84 ±9.54 sec, P <.001).

Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. Another proposed mechanism of interaction between statin and vitamin D is inhibition of CYP3A4 by statins, which displays 25-hydroxylase activity in vitro. Vitamin D deficiency leads to 'preferential shunting' of CYP3A4 for hydroxylation of vitamin D, thus decreasing the availability of CYP3A4 for statin metabolism leading to statin-induced toxicity.

This study describes the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes.

Conditions
Dyslipidemias
Being tested
Vitamin D, Simvastatin, Placebo
Keywords
simvastatin, cardiorespiratory fitness, vitamin D, exercise, mitochondria
Medical subject headings
Dyslipidemias, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

    Also called Cholecalciferol

    Vitamin D will be given to achieve normal serum levels

  • SimvastatinDrug

    Also called Statin

    Simvastatin in a dose of 40 mg will be provided to the study participants

  • PlaceboDrug

    Placebo will be provided to the study participants

Study groups in NCT02030041
Study groupRoleWhat they receive
Simvastatin and placeboExperimentalEleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl. This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week
Receives: Drug: Simvastatin; Drug: Placebo
Simvastatin and vitamin DActive comparatorEleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl. This arm will receive simvastatin 40 mg once daily and vitaminD 60,000 units once weekly , and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week
Receives: Drug: Vitamin D; Drug: Simvastatin
Vitamin D and placeboActive comparatorEleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week
Receives: Drug: Vitamin D; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Oxygen Consumption

    Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).

    Measured: Twelve weeks

  2. Skeletal Muscle Mitochondrial Content

    Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.

    Measured: Twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02030041
Sponsor's protocol ID
Simvavitd
Status last verified
Feb 2017
First submitted
23 Dec 2013
Last updated
31 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D and Simvastatin in people with Dyslipidemias, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

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 10 inclusion and 10 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peak Oxygen Consumption (time frame: Twelve weeks). The study lists 2 primary outcomes in all. 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 31 Mar 2017.

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