Phase 4 N=56 Mechanisms of Lipodystrophy in HIV-Infected Pateints
HIV Infections
Primary: Effect of Drug Regimens on Serum Triglycerides. — 228.0; 230.4; 293.4; 290.0 mg/dL — p=0.94
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=16 Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Primary: Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8 — -0.1; 0.2 millimoles per mole (mmol/mol)
N/A N=4 HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
HIV Infections
Primary: Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
Phase 2 N=103 Leptin to Treat Lipodystrophy
Lipodystrophy
Primary: Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin — 8.4; 8.1; 6.6; 7.2 percentage of glycated hemoglobin — p=<0.001
Phase 3 N=25 Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Hypoleptinemia · Generalized Lipodystrophy · Partial Lipodystrophy
Primary: Fasting Serum Triglycerides — 203; 304 mg/dL — p=0.2572
N/A N=56 Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS · HIV Infections
Primary: Change in Visceral Adipose Tissue Area From Baseline to 18 Months — -22; -4 centimeters squared — p=0.049
N/A N=17 Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
HIV Lipodystrophy
Primary: Rate of Total Lipolysis — 0.649; 0.767 mmol FFA/kg/h
Phase 2 N=5 Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
Lipodystrophy
Primary: Change in Log 10 Fasting Triglycerides. — 0.1; -0.2 log 10 mg/dl
Phase 4 N=11 Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Primary: Evaluate the Immunogenicity Associated With Daily Subcutaneous (SC) Metreleptin Treatment in Patients With Congenital Generalized Lipodystrophy (CGL) or Acquired…
Phase 2 N=10 Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
Familial Partial Lipodystrophy
Primary: Change in the Liver Triglycerides (TG). — 13.2; 6.4; 12.3; 10.6 percentage of liver triglycerides
Phase 2 N=9 Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
HIV Lipodystrophy
Primary: Insulin Resistance (HOMA Index) — 1.6; 1.8 units on a scale
Phase 3 N=263 TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Lipodystrophy · HIV Infections
Primary: Changes From Baseline in Fasting Blood Glucose at Week 52 — 0; -2; 1 mg/dL — p=>0.05
N/A N=40 Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Acromegaly
Primary: Change in Liver Fat — 0.03 Lipid/water ratio
Phase 4 N=20 Metabolic Abnormalities in HIV-infected Persons
Lipodystrophy · HIV Infection
Primary: Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent — -0.25; -0.96 mg/kg lean body mass/min
Phase 2 N=7 Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
HAART-induced Lipodystrophy and Metabolic Syndrome
Primary: Serum Lipid Levels — 228.8; 219.7; 113.0; 105.7 mg/dl
Phase 2 N=14 Therapeutic Approaches to HAART-Induced Lipodystrophy
HIV Infections · Lipodystrophy
Primary: Fasting Serum Triglycerides — 237; 341 mg/dL — p=0.84
Phase 2 N=71 Rosiglitazone Effect on Mitochondria and Lipoatrophy
HIV Infections
Primary: Change in Limb Fat at 48 Weeks — 448; 153 grams — p=0.02
Phase 3 N=326 Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
HIV Infections · Lipodystrophy
Primary: Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12 — 0.5; -32.6 Square Centimeter (cm^2) — p=<0.001
Phase 4 N=80 Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada
HIV-1
Primary: Change From Baseline in Limb Fat at Week 48 — 392; -257 grams (g) — p=0.0014
Phase 4 N=200 Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
HIV-Associated Lipodystrophy Syndrome
Primary: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 — 0.02; -0.02; 0.02; -0.01 ratio — p=0.48
Phase 2 N=50 Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
HIV Infections · Lipodystrophy · Metabolic Diseases
Primary: Change in Fat mtDNA Content — -169; 321 copies/cell
Phase 2 N=18 Cholic Acid for Hepatic Steatosis in Lipodystrophy
Hepatic Steatosis
Primary: Hepatic Triglyceride (%) — 15.9; 14.8 Fat/Fat+Water (%) — p=0.42
Phase 2 N=25 Short-term Effects of Leptin in People With Lipodystrophy
Lipodystrophy
Primary: Total Body Insulin Sensitivity — 4.4; 10.9; 5.8; 6.4 mg/kg fat-free mass/min
Phase 2 N=77 Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
HIV-Associated Lipodystrophy Syndrome · Insulin Resistance · HIV Infections
Primary: Change in Insulin Sensitivity — 0.20; 1.44; -0.63; 0.14 uU*10^-4*min*ml^-1
Phase 2 N=2 Orlistat for the Treatment of Type I Hyperlipoproteinemia
Hyperlipoproteinemia Type I · Hypertriglyceridemia
Primary: Fasting Serum Triglycerides — 705; 1827; 1511; 1007 mg/dL
N/A N=177 Diabetes and Lipid Accumulationand Heart Transplant
Diabetes Mellitus · Heart Failure
Primary: Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie — 54; 21; 0 Endomyocardial Biopsies
Phase 2 N=36 HIV and Fat Accumulation
HIV Infection
Primary: Median Change in Visceral Adipose Tissue (VAT) Volume — -4.6 cm^2
N/A N=54 Effects of Growth Hormone Releasing Hormone in HIV
HIV · HIV Lipodystrophy
Primary: Liver Fat — -2.0; 0.9 Change in hepatic lipid-to-water %
Phase 3 N=126 Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Primary: Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan — -1.7 kg — p=<0.001
N/A N=346 A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine
HIV Infection
Primary: Total Limb Fat Mass — 8.84; 9.13 kg