Beta Cell Restoration Through Fat Mitigation
BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin
over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The
primary outcome will be change in β-cell compensation for insulin resistance, which the
investigators will compare between groups. Secondary analyses will include other potential
markers of β-cell health and potential mediators of treatment-specific effects. The main
focus will be on mediators related to obesity. Clinically, the project will serve as a test
of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell
disease. Biologically, the results will provide crucial information on potential mediators
of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will
guide the development of more effective treatment and monitoring for the β-cell disease that
causes type 2 diabetes.
Advancing Postmenopausal Preventive Therapy (APPT), a progestogen-free estrogen therapy to potentially reduce atherosclerosis: a randomized-controlled trial
<p> Cardiovascular disease (narrowed or blocked blood vessels) is the leading cause of death, killing 1 of every 2 women. Atherosclerosis (hardening of the arteries) is the major cause of cardiovascular disease. More than 90% of deaths due to atherosclerosis occur after menopause when a women’s production of estrogen disappears. Research over the last decade has shown that estrogen provides potential cardiovascular benefits with low-risk to women. However, most women have a uterus that requires co-treatment with a progestogen (Provera, progesterone, etc.) to prevent thickening of the uterine lining due to estrogen. Compared to estrogen-alone therapy, traditional progestogen-estrogen therapy appears to have a greater health risk for women. </p><p>The goal of this study is to learn whether a new type of progestogen-free hormone therapy, one that protects the uterus differently so that estrogen can be delivered without risk from progestogen, has beneficial effects on hardening of the arteries in postmenopausal women. Participants in the study will be randomized, split into two groups, to receive either an FDA-approved medication designed to deliver estrogen without a progestogen (Bazedoxifene /estrogen) or placebo, a pill that does not contain an active ingredient. </p>
Not yet recruiting | atherosclerosis | Not Multisite
A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir, in Orthotopic Liver Transplant Recipients
End stage liver disease secondary to Hepatitis C virus infection is the most frequent indication for liver transplantation. However, recurrence of the disease is almost universal and is the cause of increased morbidity and mortality. At this time, attempts to treat recurrence have been difficult as the treatment is difficult to tolerate and often ineffective in the post transplant setting. In this study, we hope to learn if treatment with hepatitis C immunoglobulin (Civacir) post-operatively is safe and effective in the prevention of disease recurrence. Participants will be randomized 1:1 to 300mg/kg or control. Participants will be followed out to 6 months with monitoring of hepatic function and HCV levels. Safety data will be collected through medical follow up, examinations and follow up of hepatic function. Statistical analysis will be conducted by the sponsor to determine if the drug (and dose) are effective in preventing recurrent HCV.
Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
The purpose of this study is to evaluate the safety and effectiveness of the leadless
pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The
Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in
battery and electrodes, for permanent implantation in the right ventricle. As a leadless
pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has
the same operating principles as a conventional pacemaker.
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