Clinical Trials

The aim of the study is to investigate the effects of a 3-month resistance exercise program (in people aged 50 to 75) on muscle mass, body composition, muscle strength, brain function and cognition, muscle efficiency processing blood sugar, the body’s ability to build muscle, and fat cells.

Earlier research has shown that exercise has significant benefits in preventing certain diseases and conditions such as diabetes, dementia, heart disease, and more. We also know from other research that resistance exercise (lifting weights) and aerobic exercise (running, biking, walking), improve metabolism through separate ways on the molecular level, also called “molecular pathways.” With new and sophisticated technologies, we can analyze these molecular pathways to learn how exercise improves health. 

The purpose of the study is to understand why resistance exercise can prevent disease though analyzing the ‘molecular pathways’ in correlation with blood sugar to understand its effects on diabetes. We also will correlate these results with brain scan and cognitive tests to understand the mechanisms behind cognitive decline and dementia. 

Participants in this study will undergo a series of baseline measurements including but not limited to blood tests, brain scans, aerobic exercise tests, body composition scans, resistance exercise, a 24-hour research visit, 4 needle muscle biopsies, 2 needle fat biopsies, and an infusion of amino acids (the building blocks of muscles). 

Following the completion of the baseline visits, participants will be randomly placed into a resistance training group or a control group. 
1.    Resistance Training Group: Participants put into the resistance training program will take part in a personalized resistance training program and meet with a personal trainer four times a week for three months. Following the three months of resistance training participants will repeat the baseline visits and will be completed with the study. 
2.    Control Group: Participants put into the control group are asked not to make any lifestyle changes for 3 months. Following the 3 months, they will come back for a repeat of the baseline measurements. At this point they will have the choice to take part in the resistance training program, followed by a third set of baseline measurements. 

Remuneration is provided. 

Study title: Molecular Mechanisms of Exercise Benefits to Insulin Resistant People
IRB #: 19-006273
Principle Investigator: Dr. K Sreekumaran Nair
 

The aim of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding the treatment of obesity (Obesity Choice).

The purposes of this study are to:  evaluate the feasibility of providing a community based referral to Mayo Clinic ECH patients for weight loss by measuring the number of patients who follow through with the referral, to determine the completion rate of patients enrolled through provider referral to a community based weight loss program, and to determine the level of provider and patient satisfaction with the community based weight loss program process.

The purpose of this study is to determine if providing a vegetarian diet intervention to obese individuals over a twelve-week period can reduce chronic inflammation as well as improve cardio-metabolic parameters that are precursors to the co-morbidities associated with obesity.

The purpose of this study is to prospectively evaluate the safety and effectivenes of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing cardiac transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for the abnormal response to insulin. Likewise, we do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. We will measure muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates under both saline control (high overnight FFA) and after an overnight infusion of intravenous niacin (lower/normal FFA) to provide the first integrated examination of the interaction between FFA and muscle insulin action from the whole body to the cellular/molecular level. By identifying which steps in the insulin signaling pathway are most affected, we will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance.
Hypothesis 1: Greater trafficking of plasma FFA into intramyocellular DG will impair proximal insulin signaling and reduce muscle glucose uptake.
Hypothesis 2: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular ceramides in a way that will improve insulin signaling and increase muscle glucose uptake.
Hypothesis 3: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular DG in a way that will improve insulin signaling and increase muscle glucose uptake.

The purpose of this study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling.

Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks.

Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects will follow a 1000-1200 kcal/day-deficit diet during their participation in the study.

At 18 weeks ±4 weeks, subjects will be evaluated, and those that meet the criteria described below in section 4.3.3.2.4 will undergo an adjustment procedure wherein the balloon volume will be increased to achieve extra weight loss. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure.

At the end of the 32-week treatment period, all subjects who lost at least 5% Total Body Weight Loss (TBWL) prior to device removal will be followed for an additional 6 months. In addition, patients with device- and/or procedure-related adverse events will be followed until resolution of the event.

The purpose of this study is to provide the first integrated examination of the interaction between muscle insulin action and exercise-stimulated muscle glucose uptake in obesity from the whole body to the cellular/molecular level.

The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).

Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for muscle insulin resistance, although it has been shown that raising FFA with Intralipid can cause muscle insulin resistance within 4 hours. We do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. We propose to alter the profile and concentrations of FFA of healthy, non-obese adults using an overnight, intra-duodenal palm oil infusion vs. an intra-duodenal Intralipid infusion (both compared to saline control). We will compare the muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates, providing the first measure of how different FFA profiles alter muscle FFA trafficking and insulin action at the whole body and cellular/molecular levels. By identifying which steps in the insulin signaling pathway are most affected, we will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance.
Hypothesis 1: Palm oil infusion will result in abnormal FFA trafficking into intra-myocellular ceramides and abnormal insulin signaling.
Hypothesis 2: Intralipid infusion will result in abnormal FFA trafficking into intra-myocellular saturated DG and abnormal insulin signaling.