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Clinical Trials in Bariatric and Metabolic Medicine

| January 1, 2016

Information provided from clinicaltrials.gov


Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
Status: Not yet open for participant recruitment
Purpose: The purpose of the SWIFT Trial is to answer two research questions.
•    Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity?
•    Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?
Study Type: Observational
Study Design: Observational Model: Case Control; Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 22 Years to 80 Years
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: No
•    Sampling Method: Non-Probability Sample
•    Study Population: Study population is defined using the inclusion and exclusion criteria below. Demographic information (with the exclusion of age) is not used to determine the study population.
•    Criteria
Inclusion Criteria:
-Age 22-80 years.
-Subject is diagnosed with Non-inflammatory Degenerative Joint Disease(NIDJD).
-Subject is diagnosed with Morbid Obesity (Body Mass Index ≥ 40 kg/m2 or >35 kg/m2 with qualifying comorbid conditions such as obstructive sleep apnea or diabetes).
-Subject is a suitable candidate for cemented primary TKA with either resurfaced or non-resurfaced patellae.
-Subject is currently not bedridden.
-Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
– Subject has given voluntary, written informed consent to participate in this clinical investigation.
– Subject is comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.
Exclusion Criteria:
– Contralateral knee has already undergone TKA.
– Subject has had a contralateral amputation.
– Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
– Subject is currently experiencing radicular pain from the spine.
– Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
– Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
– Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
– Subject is medically not suitable to undergo surgery.
– Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
– Subject has a medical condition with less than 2 years of life expectancy.
– Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
– Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

Primary outcome measures: Number of bariatric surgery patients who delay or no longer need TKA. [Time Frame: 1 year post bariatric surgery] [Designated as safety issue: No]
Participants in the Test Arm will undergo bariatric surgery prior to TKA. Determine if >=20% of Test Arm participants no longer need or delay the need for TKA.
Secondary outcome measures:
•    Mobility assessment using the 400 Meter Walk test [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. Participants will be asked to complete 10 laps around cones that are 20 meters apart. During the test, participants will be asked to rate how hard they are walking and their level of knee pain. Heart rate and blood pressure will also be monitored. Mobility will be documented and analyzed to determine if there are changes throughout the course of the study.
•    Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score) [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient. Questionnaire answers will be documented and analyzed to determine if there are changes in pain, disability, and/or stiffness throughout the course of the study.
•    Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score. [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient’s ability to walk and climb stairs. Pain, function, range of motion, and joint stability will be documented and analyzed to determine if there are changes throughout the course of the study.
•    Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire. [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. Participants will be asked to complete a validated questionnaire known as PROMIS-29 to determine their quality of life. Answers to this questionnaire will be documented and analyzed to determine if there are changes in quality of life throughout the course of this study.
•    Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS) [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient’s opinion regarding their knee and its associated osteoarthritis. Answers to this questionnaire will be documented and analyzed to determine if there are changes in knee pain throughout the course of this study.
•    Change in patient satisfaction [Time Frame: 2 years post TKA surgery] [Designated as safety issue: No]. Participants will be asked to answer the following question: If you had to live the rest of your life with the symptoms you have now, how would you feel? Answers to this question will be documented and analyzed to determine if there are changes in patient satisfaction throughout the course of this study.
Sponsors: Geisinger Clinic, Danville, Pennsylvania, United States
Collaborators:
•    Cleveland Clinic Florida, Weston, Florida, United States
•    Louisiana State University Health Sciences Center in New Orleans, New Orleans, Louisiana
•    New York University School of Medicine, New York, New York, United States
•    Stanford University, Stanford, California, United States
•    University of Virginia, Charlottesville, Virginia, United States
ClinicalTrials.gov identifier: NCT02598531

Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
Status: Currently recruiting participants
Purpose: The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass, sleeve gastrectomy and lap banding. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body; 2) the effects of alcohol on blood sugar, and 3) the effects of alcohol on mood.
Study Type: Observational
Eligibility:
•    Ages Eligible for Study: 21 Years to 65 Years
•    Genders Eligible for Study: Female
•    Accepts Healthy Volunteers: Yes
•    Sampling Method: Non-Probability Sample
•    Study Population: Bariatric surgery clinic
•    Criteria
Inclusion Criteria:
-Women
– Drink alcohol at least once per month
– 21 to 65 yrs of age
Exclusion Criteria:
– Men
– Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
– Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
– Alcohol dependence
– Pregnancy, lactation or not using effective methods of birth control
– Smoking
– Anemia
– Liver disease
Primary outcome measures:
• Change from before bariatric surgery in alcohol’s Tmax, Cmax, area under the curve and elimination rates at approximately nine months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately nine months after surgery. A group of subjects will be assessed 1–5 years after surgery only.] [Designated as safety issue: No]. Time to reach maximum peak blood alcohol levels, alcohol area under the time-concentration curve and alcohol’s constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
• Change from before bariatric surgery in alcohol subjective effects at approximately nine months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately nine months after surgery. A group of subjects will be assessed 1-5 years after surgery only. ] [ Designated as safety issue: No ] Validated instruments (such as the Addiction Research Center Inventory) will be used to measured alcohol’s subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage.
Secondary outcome measures:
• Change from before bariatric surgery on alcohol’s effects on glucose homeostasis at approximately nine months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately nine months after surgery. A group of subjects will be assessed 1–5 years after surgery only.] [Designated as safety issue: No]
Sponsor: Washington University School of Medicine, Saint Louis, Missouri, United States
Collaborator: University of Missouri-Columbia, Columbia, Missouri, United States

ClinicalTrials.gov identifier: NCT01843257

Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial
Status: Currently recruiting participants
Purpose: The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.

Study Type: Interventional
Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Eligibility:
•    Ages Eligible for Study: 18 Years and older
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: Yes
•    Criteria
Inclusion Criteria:
– All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment

Exclusion Criteria:
– Patients who do not have the ability to receive text messages
– Patients who do not understand written English

Primary Outcome Measures: Percent of excess weight lost [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
• Bariatric Analysis and Reporting Outcome System (BAROS) [Time Frame: Twelve months] [Designated as safety issue: No]
Sponsor: University of Auckland, New Zealand
Collaborator: Health Research Council, New Zealand
ClinicalTrials.gov Identifier: NCT02341001

The WISE (Weightloss Intervention Surgical Effects) Brain Study (WISEBrain)
Status: Currently recruiting participants
Purpose: There will be two groups studied: One group has chosen to have weight loss surgery to help them lose weight. Another group will not chose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at changes in the structure and function of the brain tissue.
Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.
Study Type: Observational
Study Design: Observational Model: Case Control; Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 20 Years to 75 Years
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: Yes
•    Sampling Method: Non-Probability Sample
•    Study Population: Potential bariatric surgery patients will have study specific information made available to them for their consideration at the bariatric or diabetes clinics at UFHealth & Shands Hospital, or at other community locations. Flyers will be posted in many community advertising locations in the North Florida region.
•    Criteria
Inclusion Criteria:
– Body Mass Index >35
– Diabetes or no diabetes
– Compatable with MRI Scanning
– Willing to give a small blood sample on 3 occasions
– Capable of providing informed consent
Exclusion Criteria:
– Prior neurological disorder
– Mini Mental Status Exam score
– Major psychiatric disturbance (schizophrenia, chronic intractable depression,
– Coronary revascularization, peripheral vascular disease
– Severe cardio vascular disease history
– Unstable medical conditions (cancer)

Primary Outcome Measures:
• Change in BOLD fMRI signal [Time Frame: Change from baseline at 18 months] [Designated as safety issue: No]
• Brain activation changes will change in the frontal cortex and hippocampus.
Sponsor: University of Florida, Gainesville, Florida, United States
Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02137070

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