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Lipodystrophy clinical trials

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NCT ID: NCT05239130 Active, not recruiting - Lipodystrophy Clinical Trials

Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects

Start date: March 21, 2022
Phase: N/A
Study type: Interventional

The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Auralya®) significantly decrease and / or improve their appearance, results observed after 4, 8 and 12 weeks?

NCT ID: NCT05239117 Active, not recruiting - Lipodystrophy Clinical Trials

Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

The Research Question of the present study is the following: in a population of men and women presenting dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects) will Plenhyage® significantly improve the appearance of treated areas, results observed after 4, 8 and 12 weeks?

NCT ID: NCT05088460 Active, not recruiting - Clinical trials for Familial Partial Lipodystrophy

A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

LEAP
Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: - To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG - To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c) The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B: - To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia - To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B: - To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis - To evaluate the effect of REGN4461 on hunger - To evaluate safety and tolerability of REGN4461 - To characterize the concentration profile of REGN4461 over time - To assess immunogenicity to REGN4461

NCT ID: NCT04517253 Active, not recruiting - Clinical trials for Aicardi Goutieres Syndrome

A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS

Start date: October 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and Aicardi-Goutières Syndrome (AGS).

NCT ID: NCT04159415 Active, not recruiting - Clinical trials for Generalized Lipodystrophy

Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL). The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.

NCT ID: NCT04026178 Active, not recruiting - Clinical trials for Generalized Lipodystrophy

Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy

Start date: November 14, 2018
Phase: Phase 4
Study type: Interventional

MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.

NCT ID: NCT03283475 Active, not recruiting - Thigh Lipodystrophy Clinical Trials

Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift

thigh lift
Start date: May 14, 2017
Phase: N/A
Study type: Interventional

The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- - Liposuction only. - thigh lift. - Liposuction assisted thigh lift.

NCT ID: NCT02342223 Active, not recruiting - Clinical trials for HIV Facial Lipoatrophy

Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy

Start date: February 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety of Voluma and see what effects it has on HIV facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.

NCT ID: NCT02262806 Active, not recruiting - Diabetes Clinical Trials

Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy

Start date: October 14, 2014
Phase: Phase 2
Study type: Interventional

Background: - Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: - To test the safety and effectiveness of metreleptin. Eligibility: - People age 6 months and older with partial lipodystrophy who - have received metreleptin through NIH studies and shown improvement AND - cannot get metreleptin other ways. Design: - Participants will come to NIH approximately every 6 months during year one, then every 1 2 years. Financial assistance may be available for travel within the U.S. - At visits, participants will get a supply of metreleptin to take home for daily injections, or it can be shipped to them inside the U.S. They will have: - plastic catheter placed in an arm vein. - blood tests, urine collection, and physical exam. - oral glucose tolerance test, drinking a sweet liquid. - ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the skin and pictures are taken of the organs. - echocardiogram, which takes pictures of the heart with sound waves. - Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they breathe is measured. - Participants will have up to 3 DEXA scan x-rays per year. - Participants may have: - annual bone x-rays. - liver biopsies every few years. A needle will be inserted into the liver to obtain a small piece. Participants will sign a separate consent for this. - Participants must be seen regularly by their local doctors and have blood tests at least every 3-6 months at home.

NCT ID: NCT01612858 Active, not recruiting - HIV Infection Clinical Trials

Metabolic Abnormalities in HIV-infected Persons

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.