Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

Learn more about:
Related Clinical Trial
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH. Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome Exercise and Pioglitazone for HIV-Metabolic Syndromes Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults Yoga for the Management of HIV-Metabolic Syndromes Pravastatin for Hyperlipidaemia in HIV. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth Exercise for Patients With HIV Infections Lactate Metabolism Study in HIV Infected Persons Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells Growth Hormone Dynamics and Cardiac Steatosis in HIV The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Detraining in People Living With HIV/AIDS SHARE: Simple HAART With Abacavir, Reyataz, and Epivir The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Metabolism and Body Shape of Healthy Children and Children With Chronic Infections Changing to Nonprotease Inhibitor Treatment to Improve Side Effects Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs White Light Scanning to Aid Body Contouring: A Pilot Project Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy The Cleveland Cardiometabolic Cohort Metabolic Abnormalities in HIV-infected Persons Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients. Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome Effects of Short-term Growth Hormone in HIV-infected Patients Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid Raltegravir Therapy for Women With HIV and Fat Accumulation The PREFORM Study: A Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring Effects of IGF-I in HIV Metabolic Disease Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy Effects of Growth Hormone Releasing Hormone in HIV A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy Body Composition and Adipose Tissue in HIV Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue CONFORM: Rotational Fractional Resection for Submental Contouring Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy TH9507 in Patients With HIV-Associated Lipodystrophy TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy Energy Expenditure of People Living With HIV/AIDS Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Egrifta Replacement and Sleep Disordered Breathing Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients Low Energy Diet and Familial Partial Lipodystrophy Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabetes and Obesity Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy Role of the Autonomic Nervous System in HIV-Lipodystrophy Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome Therapeutic Approaches to HAART-Induced Lipodystrophy Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift Leptin to Treat Lipodystrophy Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat Corticosteroid-induced Lipodystrophy and Adipokines Short-term Effects of Leptin in People With Lipodystrophy Leptin to Treat Lipodystrophy Lipodystrophy Connect Patient Registry An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Brief Title

Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

Official Title

Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients

Brief Summary

      To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently
      available antiretroviral drugs, and the prevalence of associated metabolic syndrome in
      HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the
      severity of fat accumulation and antiretroviral drug use.
    

Detailed Description

      Cross-sectional evaluation of two groups of patients:

        -  patients receiving currently available drugs, in order to determine the changes in fat
           accumulation by successive dual X-ray absorptiometry (DXA) determinations

        -  patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and
           total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of
           hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance
           (insulin resistance or diabetes), fat accumulation (waist circumference) and
           hypertriglyceridemia.

      The prevalence of Metabolic syndrome will be evaluated according to the different definitions
      (IDF, NCEP-ATP III, WHO).
    


Study Type

Observational


Primary Outcome

Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)

Secondary Outcome

 Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome

Condition

Lipodystrophy

Intervention

Evaluation of metabolic syndrome


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

276

Start Date

February 2016

Completion Date

June 2018

Primary Completion Date

February 2018

Eligibility Criteria

        Inclusion Criteria:

          -  HIV infection

          -  Older than 18 years

          -  Receiving first or second antiretroviral regimen or

          -  Previous evaluation and classification of lipodystrophy syndrome

        Exclusion Criteria:

          -  Pregnancy

          -  Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids
             or hormones before inclusion

          -  Patients who had received antiretroviral drugs known to produce fat disturbances (for
             lipodystrophy prevalence objective)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jose L Casado, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT02614027

Organization ID

460/15

Secondary IDs

EC 460/15

Responsible Party

Sponsor

Study Sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas


Study Sponsor

Jose L Casado, MD, Principal Investigator, Ramon y Cajal Hospital


Verification Date

June 2018