Clinical Trials

Long Term Extension Trial of Setmelanotide

Rochester, MN

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Long Term Extension Trial of Setmelanotide

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2/3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this extension study of up to an additional 2 years duration beyond the index trial for patients who have completed a previous study of setmelanotide for genetic obesity disorders upstream of the MC4 receptor in the melanocortin-leptin pathway. Since continued assessments of the safety and efficacy of setmelanotide are the same in this extension protocol regardless of the disease studied in the index protocol, all patients can be followed in this single extension protocol. Nevertheless, the analysis of each individual disease will be performed separately with the ability to combine data from the original index protocol and this extension protocol on a disease specific basis. For patients who qualify and consent, the study will start immediately on the completion of their index protocol such that there are no gaps in setmelanotide therapy , if possible. Efforts should be made to allow the last visit of a prior index trial or an index trial extension phase and the initial visit of this comprehensive long-term extension trial to occur on the same day. Patients will continue taking the same dose of setmelanotide that they were taking when they finished the index protocol. Dose changes can be made for safety or efficacy. Patients will be assessed in the clinic approximately every 3 months for vital signs, adverse events, concomitant medications, weight, waist circumference, and hunger score. Safety laboratories will be collected at each visit and additional assessments will be done on a yearly basis. In general assessments will be less frequent and burdensome than was required in their index protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 21-007803
NCT ID:
NCT03651765
Sponsor Protocol Number:
RM-493-022

Determining Lipid Content in Stool After Alpha-cyclodextrin

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A Study Providing the Use of Under Desk Elliptical Devices for Promoting Physical Activity Among Employees

Rochester, MN

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A Study Providing the Use of Under Desk Elliptical Devices for Promoting Physical Activity Among Employees

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to determine if employees will use under desk foot pedal elliptical devices at their workstation to increase their level of physical activity.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-010079
Sponsor Protocol Number:
14-010079

Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

Rochester, MN

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Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Currently in the United States about 97 million adults are considered obese, accounting for about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0 Laser (which will be used in this study) has been approved by the FDA (K123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by the FDA on June 2012 for weight management in people with a BMI of > 27 kg/m2 (overweight) when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in people with a BMI > 30 kg/m2 (obese). The purpose of this pilot study is to obtain preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory biomarkers, blood sugar, and cholesterol.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-002370
NCT ID:
NCT02129608
Sponsor Protocol Number:
14-002370

Insulin Regulation of Lipolysis and Lipolysis Proteins

Rochester, MN

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Insulin Regulation of Lipolysis and Lipolysis Proteins

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
0
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to determine whether impaired insulin-induced suppression of lipolysis (as measured by IC50) is related to lipolysis proteins in groups of volunteers known to vary widely with regards to abdominal adipocyte size and regulation of adipose tissue lipolysis, and whether the improved insulin regulation of lipolysis resulting from treatment with the PPARγ agonist pioglitazone, with or without weight loss, can be linked to specific changes in sets of PPARγ-responsive adipocyte lipolysis proteins in UBO adults.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 17-009837
NCT ID:
NCT03866408
Sponsor Protocol Number:
17-009837

Eosinophils in Human Adipose Tissue

Scottsdale/Phoenix, AZ

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Eosinophils in Human Adipose Tissue

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This study aims to assess adipose tissue-eosinophil content and adiopose tissue metabolism 3 months after endoscopic gastroplasty weight loss procedure.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Scottsdale/Phoenix, Arizona: 21-000959
NCT ID:
NCT04898400

Effect of 12-Week Vegetarian Diet Intervention on Inflammatory Status and Cardio-Metabolic Parameters

Rochester, MN

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Effect of 12-Week Vegetarian Diet Intervention on Inflammatory Status and Cardio-Metabolic Parameters

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 18-006901
Sponsor Protocol Number:
18-006901

A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients

Rochester, MN

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A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to compare a ventilation strategy using higher levels of positive end expiratory pressure and recruitment maneuvers to one using lower levels of positive end expiratory pressure without recruitment maneuvers in obese patients at an intermediate-to-high risk for post surgery respiratory complications.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 14-005465
NCT ID:
NCT02148692
Sponsor Protocol Number:
ANE-PROBESE

The Development and Testing of a Shared Decision Making Encounter Tool for Weight Management Decisions

Rochester, MN, Jacksonville, FL

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The Development and Testing of a Shared Decision Making Encounter Tool for Weight Management Decisions

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 18-003484
- Jacksonville, Florida: 18-003484
Sponsor Protocol Number:
18-003484

Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Rochester, MN

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Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 16-004253
NCT ID:
NCT03115424
Sponsor Protocol Number:
16-004253

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Search Results 31-40 of 153 for obesity

Long Term Extension Trial of Setmelanotide

Determining Lipid Content in Stool After Alpha-cyclodextrin

A Study Providing the Use of Under Desk Elliptical Devices for Promoting Physical Activity Among Employees

Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

Insulin Regulation of Lipolysis and Lipolysis Proteins

Eosinophils in Human Adipose Tissue

Effect of 12-Week Vegetarian Diet Intervention on Inflammatory Status and Cardio-Metabolic Parameters

A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients

The Development and Testing of a Shared Decision Making Encounter Tool for Weight Management Decisions

Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

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