Adiposity Clinical Trial
Official title:
WU 360: Assessing the Impact of Integrase Strand Transfer Inhibitors (INSTI) to Protease Inhibitor (PI) Switch on Insulin Sensitivity and Fat Metabolism (ADIPOSITY): a Sub-study of DEFINE
A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.
Synopsis Full study title: Assessing the impact of integrase strand transfer inhibitors (INSTI) to protease inhibitor (PI) switch on insulin sensitivity and fat metabolism (ADIPOSITY): a sub-study of DEFINE Endpoints and objectives: The following endpoints will be determined 12 and 24 weeks after switch from an INSTI-based antiretroviral therapy (ART) regimen to a PI-based regimen: Primary endpoint: Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT). Secondary endpoints: 1) Change in insulin sensitivity (SI) at 24 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT); 2) Change in insulin secretion during the fsOGTT assessed by using C-peptide deconvolution; 3) Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI); 4) Change in adipocyte size by the osmium tetroxide fixation technique; and 5) Change in expression of genes associated with adipose tissue development, lipogenesis, inflammation and endocrine function by RNA sequencing. Hypothesis: Insulin sensitivity will improve following switch from INSTIs to PIs ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02558920 -
Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
|
||
| Recruiting |
NCT04098679 -
Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)
|
||
| Terminated |
NCT03631680 -
The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause
|
||
| Recruiting |
NCT05486338 -
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
|
N/A | |
| Not yet recruiting |
NCT04096404 -
Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
|
N/A | |
| Completed |
NCT02975258 -
Adiposity and Airway Inflammation in HIV-Associated Airway Disease
|
N/A | |
| Enrolling by invitation |
NCT01971840 -
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
|
N/A | |
| Completed |
NCT02151825 -
Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
|
N/A | |
| Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
| Active, not recruiting |
NCT03575897 -
Serial Assessment of Body Fat Accrual in Very Preterm Infants
|
N/A | |
| Completed |
NCT03642223 -
Central and Peripheral Adiposity and Iron Absorption
|
N/A | |
| Active, not recruiting |
NCT03542370 -
Umbrella Review of the DASH Dietary Pattern and Cardiometabolic Risk
|
||
| Completed |
NCT03898518 -
The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
|
N/A | |
| Recruiting |
NCT05324488 -
Diabetes Registry Graz for Biomarker Research
|
||
| Completed |
NCT02654535 -
Meta-analyses of Nuts and Risk of Obesity
|
||
| Completed |
NCT01922791 -
Nutrition and Pregnancy Intervention Study
|
N/A | |
| Recruiting |
NCT02041039 -
REWARD SYSTEM RESPONSES TO FOOD AROMAS
|
||
| Completed |
NCT03219125 -
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
|
||
| Recruiting |
NCT05433688 -
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
|
||
| Active, not recruiting |
NCT05654051 -
The SLIM LIVER Study
|
Phase 2 |