Clinical Trials in Bariatric and Metabolic Medicine

| May 1, 2017

Information provided from clinicaltrials.gov


Effect of a Technology-Based Intervention on Weight Change Post-Bariatric Surgery
Status: This study is currently recruiting participants.
Purpose: The primary aim of this study is to examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care. Forty participants at 1-year post bariatric surgery will be randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery). Analyses will be conducted to compare these interventions for differences in body weight, body composition, fitness, physical activity, engagement, psychosocial measures, and intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable monitor that provides feedback on energy expenditure and physical activity, electronic tracking of dietary intake, and integration of an electronic scale to provide comprehensive feedback to the participant on all components of weight management. TECH participants will receive a monthly telephone call from the intervention staff to provide guidance on their weight management efforts.
Study Type: Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Eligibility:
•    Ages Eligible for Study: 18 Years to 60 Years (Adult)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: Yes
Criteria:
Inclusion Criteria:
-Between the ages of 18-60 years.
-1-year post-bariatric surgery.
-Able to walk at 3 miles per hour during a cardiorespiratory fitness test.
Exclusion Criteria:
-Reports not having access to a computer, access to the Internet, email, or the availability to download software onto a computer.
-Reports not having a smart phone device that is compatible with the Jawbone UP3 System that will be examined in this study.
-Has a physical limitation that would prevent engaging in physical activity.
-Reports being treated for a current medical condition that could affect body weigh (diabetes mellitus, cancer, chronic renal insufficiency, hyperthyroidism, hypothyroidism, chronic liver disease).
-Reports current congestive failure, angina, uncontrolled arrhythmia, symptoms indicative of increased risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (deep vein thrombosis).
-Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥100 mmHg or taking medication to control blood pressure that affects heart rate.
-Reports being treated for a psychological issue (i.e., depression, bipolar disorder, etc).
-Taking prescription or over-the-counter medications that affect body weight and metabolism.
-Currently participating in an exercise or weight control study or a current participant in a commercial weight reduction program.
-Currently being treated for an eating disorder.
-Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 6 months.
-Planning on relocating outside of the greater Pittsburgh area within the next 6 months.
Primary Outcome Measures:
•    To examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care over the subsequent 6 months. [ Time Frame: 1 year after bariatric surgery – months 12-18 (6 month intervention period) ]
•    Body Weight (5 minutes; 0, 3, 6 months): Body weight will be measured to the nearest 0.1 kg on a Tanita WB-110A digital scale (Tanita Corporation; Arlington Heights, IL). Measures will be taken in a light-weight hospital gown with shoes and accessories removed.
Secondary Outcome Measures:
•    See clinical trials website
Sponsors and Collaborators:
•    University of Pittsburgh, Pittsburgh, Pennsylvania
ClinicalTrials.gov identifier: NCT02867696

The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
Status: This study is currently recruiting participants.
Purpose: In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children’s Medical Center of Israel (SCMCI).
Study Type: Observational
Study Design:
Observational Model: Cohort
Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 11 Years to 18 Years (Child, Adult)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: No
•    Sampling Method: Probability Sample
•    Study Population: Adolescents with morbid obesity who will undergo bariatric surgery
Criteria:
Inclusion Criteria:
-Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children’s Medical Center during 2016-2018
Exclusion Criteria:
-Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
Primary Outcome Measures:
•    Change from Baseline Lung Clearance Index [Time Frame: 3 months post op]
Secondary Outcome Measures:
•    Change from Baseline High sensitivity C reactive protein [Time Frame: 3 months post op]
Sponsors and Collaborators: Rabin Medical Center, Petach Tikva, Israel
ClinicalTrials.gov identifier: NCT02644174

Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery
Status: This study is not yet open for participant recruitment.
Purpose: Obesity is a major public health problem in developed and developing countries, causing a range of respiratory and metabolic changes. There is a strong correlation between obesity and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the quality of life, but clinical treatment it is not effective for a long period. In this context, currently bariatric surgery is an option for the real weight loss in the long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with obesity. The primary aim of this protocol are to assess the inflammatory profile of severe obese patients undergone to bariatric surgery, through systemic and adipose markers of inflammation. A secondary objective is study the impact of this surgery on sleep variables and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects with severe obesity. Will participate in this study, patients with severe obesity (BMI > 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to participate in the study. Are excluded patients with BMI > 55 kg/m2, clinical instability, mental instability or significant and unrealistic expectations of surgery. Patients will be assessed before and after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of clinical history, vital signs, neck and waist circumference, clinical analysis of blood inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of life and personal satisfaction questionnaires.
Study Type: Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Eligibility:
•    Ages Eligible for Study: 18 Years to 65 Years (Adult)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: No
Criteria:
Inclusion Criteria:
-Patients eligible for the trial must comply with all of the following at randomization:
-male and female patients aged 18 to 65 years,
-grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
-awaiting bariatric surgery,
-with documented history of conventional weight loss attempts having proven unsuccessful over time,
-and if they are able to understand and agreement to participate in the study through a signed term of informed consent.
Exclusion Criteria:
-Any medical condition rendering surgery too risky;
-BMI above 55 kg/m2;
-Unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment;
-Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment;
-Lack of safe access to abdominal cavity or gastrointestinal tract;
-Abusive alcohol use or drug use.
-Cancer
-Any cardiorespiratory condition opposite indicate the surgical procedure.

Primary Outcome Measures:
•    Change in systemic immune response after bariatric surgery. [Time Frame: Baseline immune response to 180 days.] Systemic markers of inflammation through fasting blood samples biochemical indexes.
•    Change in systemic adipose inflammation response after bariatric surgery. [Time Frame: Baseline adipose inflammation response to 180 days.] Systemic markers of inflammation through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots.

Secondary Outcome Measures:
•    Alterations in sleep quality after bariatric surgery. [Time Frame: 180 days] Study sleep patterns through full standard polysomnography.
•    Changes in pulmonary function after bariatric surgery. [Time Frame: 180 days] Assess pulmonary function through spirometry.
•    Changes in maximal ventilatory pressures after bariatric surgery. [Time Frame: 180 days] Assess maximal inspiratory and expiratory pressures through vacuometry.
•    Changes in health related quality of life after bariatric surgery. [Time Frame: 180 days]
•    Changes in quality of life through Short Form-36 and BAROS questionnaires.
Sponsors and Collaborators:
•    University of Nove de Julho
•    Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier: NCT02409160

Mindfulness in Preparation to Bariatric Surgery (PConscience)
Status: This study is currently recruiting participants.
Purpose: Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement.
The goal is to evaluate the efficacy of “mindfulness” versus an active control group in bariatric surgery.
Study Type: Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Eligibility:
•    Ages Eligible for Study: 18 Years and older (Adult, Senior)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: No
•    Criteria
Inclusion Criteria:
-Adult patients: over 18 years
-Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery
-Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss
-Absence of any psychiatric counter-argument
Exclusion Criteria:
-Subjects responding to inclusion criteria of the French National Authority for Health
-Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without psychotic disorders, major depressive disorder, or suffering from anti-social personality disorder
-Patient registered for social security
-Free, signed and informed consent
Primary Outcome Measures:
•    Psychometric evaluation [Time Frame: About 15 minutes] Tool: SBC-20 – Scale of Body Connexion
•    Psychometric evaluation [Time Frame: About 15 minutes] Tool : TAS-20 – The twenty-item Toronto Alexithymia Scale
•    Psychometric evaluation [Time Frame: 15 minutes] Tool: BAQ-18- Body Awareness Questionnaire
Sponsors and Collaborators:
•    University Hospital, Grenoble, La Tronche, France
ClinicalTrials.gov Identifier: NCT02854306

Extension of the 5As Team Study for Improved Provider Obesity Management to Physicians and Medical Trainees (Part 2) (5AsT-MD2)
Status: This study is currently recruiting participants.
Purpose: Results from the 5As Team (5AsT) Study have identified critical gaps in medical school curricula on obesity, leading to a wave of new family physicians who are unconfident and poorly equipped to manage obesity with their patients. In an effort to address this gap, all first year medical residents training in family medicine at the University of Alberta during the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part of the Doctor-Patient Relationship Course. The workshop will focus on knowledge, intangible skills and practicing the 5AsT approach to obesity management with patients of all demographics. The objective of the 5AsT MD2 study is to evaluate the impact of this workshop on the residents’ attitudes and beliefs about obesity, as well as their level of confidence in using key aspects of the 5As of obesity management to help their patients. Participants will be asked to complete and submit pre- and post- knowledge assessments, narrative reflections and questionnaires assessing their beliefs and attitudes towards people living with obesity as part of their core requirements for the course. For those who consent to participate in the study and release their de-identified course assignments, we will evaluate the impact of the workshop using both quantitative and qualitative methods. The results will assist us in gaining information that may help us improve and further refine curricular materials for physicians and medical trainees.
Study Type: Observational
Study Design:
Observational Model: Case-Only
Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 19 Years and older   (Adult, Senior)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: Yes
•    Sampling Method: Non-Probability Sample
Criteria:
Inclusion Criteria:
-Participants must be first year medical residents training in family medicine at the University of Alberta. They will be recruited from the Obesity Management Workshop that is a required component of their course on Doctor-Patient Relationships. All participants must be over the age of 18 and be able to communicate effectively in English.
Exclusion Criteria:
-If participants are unable to communicate effectively in English, they will not be able to participate in the study. The Obesity Management Workshop will be presented in English and participants must be able to understand the presentation and written documents that they are being asked to complete.
Primary Outcome Measures:
•    Changes in Attitudes Towards Obese Persons (ATOP) [Time Frame: baseline, 3 weeks] Self-reported measure about a person’s attitudes towards obese persons to see whether their attitude towards people living with obesity changed as a result of the knowledge gained through the obesity management workshop.
•    Changes in Beliefs About Obese Persons (BAOP) [Time Frame: baseline, 3 weeks] Self-reported measure about a person’s beliefs about obese persons to see whether their beliefs about people living with obesity changed as a result of the knowledge gained through the obesity management workshop.
•    Changes in Self-Reported Comfort Level (Pre- and Post- Assessment Scale) [Time Frame: baseline, 3 weeks] The pre- and post- questionnaire is a self-reported measure of the resident’s comfort level around each of the 5 areas of the 5A’s Obesity Management. Questions related to each element of the 5A’s are rated using a 5 point Likert Scale.
•    Qualitative: Narrative Reflections [Time Frame: baseline, 3 weeks] Personal reflection on how the experience and the workshop made the person feel. These will be analyzed using qualitative analysis to see how the workshop may have affected views, beliefs and their practice.
Sponsors and Collaborators:
•    University of Alberta
•    Alberta Innovates Health Solutions
ClinicalTrials.gov Identifier: NCT02648308

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