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Research Bites

| June 1, 2016

Clinical Trials in Bariatric and Metabolic Medicine

Information provided from clinicaltrials.gov


Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery (BAREVAL)
Status: This study is currently recruiting participants.
Purpose: The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient’s progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Basic Science
Eligibility:
•    Ages Eligible for Study: 18 Years and older
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: No
•    Study Population: Study population is defined using the inclusion and exclusion criteria below.
•    Criteria
Inclusion Criteria:
– Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
– Patients treated by bariatric surgery on CHU Montpellier
– Agreed to participate to the study by signing an informed consent
– Eligible to health insurance
Exclusion Criteria:
– Unable to follow the patient in the long term (foreign patients, surgical use …)
– Inability to follow in the long run
Primary outcome measures:
•    Assessment of the long-term efficiency of bariatric surgery on weight loss [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of weight loss
Secondary outcome measures:
•    Assessment of the long-term efficiency of bariatric surgery on diabetes [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of blood glucose, HbA1c and diabetes medications
•    Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of Systolic Blood Pressure and blood pressure medications
•    Assessment of the long-term efficiency of bariatric surgery on dyslipidemia [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications
•    Assessment of the long-term efficiency of bariatric surgery on rheumatism [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of rheumatism medications
•    Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of respiratory pathologies medications
•    Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome [Time Frame: Change from intervention to 3 months] [Designated as safety issue: No] polysomnography tests
•    Assessment of the long-term efficiency of bariatric surgery on quality of life [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of quality of life questionnaires (SF36 and BAROS)
•    Assessment of medico-economic impact of bariatric surgery [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Comparison of health insurance data
•    Assessment of mortality of bariatric surgery [Time Frame: Change from intervention to 5 years] [Designated as safety issue: No]
•    Assessment of the date of death
Sponsors and Collaborators: University Hospital, Montpellier
ClinicalTrials.gov identifier: NCT02310178

Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients (MYGOODTRIP)
Status: This study is not yet open for participant recruitment.
Purpose: The goal of clinical trial is to evaluate the impact of use of health-connected devices and of an Internet-based Intensive follow-up on physical activity recovery during the 6-month period after bariatric surgery in obese patients.

90 patients with morbid obesity, having recently benefited from an act of bariatric surgery will be recruited for clinical trial if they meet the inclusion and no inclusion criteria. This is a single-center, open, controlled, randomized, 2 parallel-groups: “Mobility Coaching” group and “Diet Coaching” group

The “Diet Coaching” group will be the “control group” of “Mobility Coaching” group and vice versa.

Patients in both groups will be equipped with a connected-scale and a wristwatch equipped with a pedometer connected. The online tools available to patients will be used to motivate patients to progress and alert the coaches and the medical team in case of difficulties to achieve the objectives.

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 to 65 Years
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: No
•    Criteria
Inclusion Criteria:
– Primo-surgery bariatric surgery a week before their inclusion
– Absence of surgical side events related to the surgical procedure
– Adult female or male
– Weight ≤ 150 kg
– Knowing read and write French routinely,
– Possessing an internet connection at home,
– Possessing and knowing how to use a computer or tablet,
– Owning a smartphone,
– Affiliated with a social security scheme
– Not Trust
– Having signed the informed consent letter
Non-inclusion criteria
– Patient with major disabilities causing a definitive loss of mobility
Exclusion Criteria:
– None
Primary Outcome Measures:
•    Change from baseline mean number of steps per day at 6th month [Time Frame: Period from Day 164 to Day 179] [Designated as safety issue: No]
•    The primary endpoint is the difference between mean number of steps recorded by the pedometer during the last 15 days of the 6th month (Period Day 164 to Day 179) and the mean number of steps per day recorded in the last 15 days of the first month (Period Day 15 to Day 30).
Secondary Outcome Measures:
•    Change from baseline mean daily energy expenditure at 6th month [Time Frame: At 6th month] [Designated as safety issue: No] Estimated by self-administrated questionnaire (RPAQ)
•    Change from baseline mean daily energy expenditure at 3rd month [Time Frame: At 3rd month] [Designated as safety issue: No] Estimated by self-administrated questionnaire (RPAQ)
•    Change from baseline weight at 6th month [Time Frame: At 6th month] [Designated as safety issue: No]
•    Change from baseline weight at 3rd month [Time Frame: At 3rd month] [Designated as safety issue: No]
•    Percent of patients having nutritional deficiency in vitamins and / or minerals [Time Frame: At 6th month] [Designated as safety issue: Yes] Biological measurements
•    Change from baseline Quality of life at 6th month [Time Frame: At the 6th month] [Designated as safety issue: No] Estimated by self-administered quality-of-life questionnaire (EQVOD)
•    Change from baseline Quality of life at 3rd month [Time Frame: At the 3rd month] [Designated as safety issue: No] Estimated by self-administered quality-of-life questionnaire (EQVOD)
•    Change from baseline mean number of steps per day at 3rd month [Time Frame: Period from Day 75 to Day 90] [Designated as safety issue: No]
Sponsors and Collaborators:
•    My Goodlife SAS
•    European Georges Pompidou Hospital
•    Hospital Ambroise Paré Paris
•    French Environment and Energy Management Agency
ClinicalTrials.gov Identifier: NCT02716480

Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery
Status: This study is currently recruiting participants.
Purpose: This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).

It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.
Study Type: Observational
Study Design: Observational Model: Case-Only; Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 18 Years to 70 Years
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: No
•    Sampling Method: Probability Sample
•    Study Population: Obese subjects with renal pathology (decrease in glomerular filtration and/or albuminuria/proteinuria) who are candidates to bariatric surgery.
•    Criteria
Inclusion Criteria:
– Age 18-70 years (male or female).
– BMI >35 kg/m2 who meet the following criteria: a) GFR 30-60 ml/min and proteinuria>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. b) GFR >60 ml/min and proteinuria >(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
– Patients with BMI> 40 kg/m2 with a GFR> 30 ml/min and proteinuria >(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
– Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.
Exclusion Criteria:
– Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.
– Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.
– Patients with poorly controlled blood pressure (SBP> 170 mmHg or DBP> 110 mmHg).
– Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.
– Patients treated with steroids or other immunosuppressants.
– Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.
– Patients who are pregnant or lactating.
– Patients who do not sign the informed consent.
– A slight chance of compliance with visits scheduled in the protocol.
Primary Outcome Measures:
•    Reduction (measured as a percentage) of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery [Time Frame: 24 months] [Designated as safety issue: No]
Sponsors and Collaborators:
•    Enrique Morales Ruiz, MD
•    Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT02644928

The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease
Status: This study is currently recruiting participants.
Purpose: Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease. In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later fibrosis, cirrhosis, and eventually some patients may develop hepatocellular carcinoma with or without cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an active area for research. The diagnosis of NAFLD is achieved through histological examination of liver biopsies (invasive), non-invasive markers using serum biomarkers and imaging techniques are still under development. Pathological diagnosis can be then subcategorized based on several scoring systems. More widely used are the Brunt Score or NAS (NAFLD activity score) and the Kleiner’s modified NAS.
Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an additional source of fat in the liver. Due to the strong association of NAFLD with obesity, weight reduction procedures are used for the management of NAFLD. In fact, this has been shown to be effective by several studies. However, other studies have reported liver deterioration after bariatric intervention. This conflict is what makes the effects of bariatric procedures a challenging field for further studies. Consequently in this study we are aimed to examine histologic, metabolic and liver function changes induced by the different therapeutic bariatric procedures.
Study Type: Interventional
Study Design: Observational Model: Cohort; Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: 18 Years to 60 Years
•    Genders Eligible for Study: Both
•    Accepts Healthy Volunteers: No
•    Sampling Method: Non-Probability Sample
•    Study Population: NAFLD patients
•    Criteria
Inclusion Criteria:
– Age between 18 to 60 years.
– Eligible for obesity surgery according to the following criteria:
– BMI > 30 kg/m2.
– Ability to demonstrate eating habit control by reducing 10% of the original weight prior to surgery
– Pass the nutritional and the psychological assessment
– Pass the preoperative testing to determine the operative risk
– Ultrasound diagnosis of NAFLD prior to surgery.
– Written informed consent.
Exclusion Criteria:
– Unwilling to take part in the study, or asked to be removed from the study at any time.
– History of alcohol intake > 20g/day for 5 or more years
– Evidence autoimmune hepatitis, chronic hepatitis B or C virus, HIV, genetic hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease, or cirrhosis.
– Pregnancy.
– Currently taking known hepatotoxic medications.
– Failure to attend follow-up for a minimum of 1 year.
– Non-Saudi patients
Primary Outcome Measures:
•    Assessment of NAFLD histological changes after bariatric surgery (adjustable gastric banding, sleeve gastrectomy, gastric bypass, and duodenal switch). [Time Frame: Intra-operatively, 3 months and 1 year postoperatively.] [Designated as safety issue: Yes]
•    Histological evaluation is done by applying the NAFLD activity score (NAS). The stage of fibrosis will be determined by the five-point (stage 0 to 4) scale.
Secondary Outcome Measures:
•    Assessment of liver function after bariatric surgery. [Time Frame: Preoperatively, 3 months, 6 months, 1 year and annually for 5 year postoperatively. ] [ Designated as safety issue: Yes ]
– Measure serum albumin, bilirubin, INR, anti-thrombin-III, ALT, GGT, AST, protein C and S levels.
– Measure albumin synthesis using radiolabeled amino acids.
•    Assessment of NAFLD associated morbidities by detecting the systemic inflammatory changes after bariatric surgery. [Time Frame: preoperatively, 3 months, 6 months, 1 year and annually for 5 year postoperatively.] [Designated as safety issue: Yes]
– Study systemic inflammatory changes by measuring the serum levels of several inflammatory mediators: ESR, C-reactive protein, interleukins (IL-1, IL-4, IL-6, IL-8, IL-10, IL-16), adipokines (adiponectin, leptin, adipsin and Chemerin), MCP1, osteopontin, and growth factors (TNF-α, and VEGF).
•    Assessment of NAFLD associated morbidities by detecting the local inflammatory changes after bariatric surgery. [Time Frame: Baseline (tissues obtained intraoperatively).] [Designated as safety issue: Yes ]
– Hepatic expression of α-SMA, collagen α1, TGF-β1, MCP-1, IL-6, IL-8, leptin and adiponectin receptors. PAI1, ACRP30, ADIPOQ.
– Visceral adipose tissue to assess the expression of NOD-like receptor pyrin domain-containing-3 inflammasome (Nlrp3); are inflammatory markers that recognize certain signals that leads to caspase-1 activation and subsequent IL-1 and IL-18.
– Subcutaneous adipose tissue to assess the expression of adiponectin, IL-6 and TNF-α.
•    Assessment of NAFLD associated morbidities by detecting the metabolic changes after bariatric surgery. [Time Frame: Preoperative, 3 months, 6 months, 1 year and annually for 5 years postoperatively.] [Designated as safety issue: Yes]
– Hormonal changes: serum levels of ghrelin, peptide YY, amylin, cholecystokinin, insulin, glucagon, epinephrine, and cortisol.
– Non-hormonal changes: HbA1c, FFA, HDL, cholesterol, triglycerides, fasting glucose.
•    Assessment of NAFLD associated morbidities by detecting the endothelial changes after bariatric surgery. [Time Frame: Preoperative, 6 months, 1, 2 and 5 years postoperatively.] [Designated as safety issue: Yes]
– Doppler Ultrasound (Duplex) for the carotid arteries.
– Measuring the levels of progenitor cells.
•    Studying the genetic factors expressing for the inflammatory changes differences in responders. [Time Frame: Baseline (for liver, visceral and subcutaneous fat). Postoperatively (for liver only): 3 months, 1 year and 5 years after the surgery.] [Designated as safety issue: Yes]
– TMA construction using the formalin stored liver, visceral fat and abdominal wall muscle.
– Detecting mRNA expression from frozen tissue (liver, visceral fat and abdominal wall muscle) with respect of inflammation, insulin action, lipid metabolism, liver regression and apoptosis.
– Deep gene sequencing for subgroup of patients with variables clinical responses or with genetic differences determined form the above testing.
•    Long-term follow-up to examine the correlation between the type of surgery and clinical outcomes associated with NAFLD (liver cirrhosis, incidence of cancer, and mortality). [Time Frame: 5 years] [Designated as safety issue: Yes]
– Histological evaluation is done by applying the NAFLD activity score (NAS). The stage of fibrosis will be determined by the five-point (stage 0 to 4) scale.
•    Testing the efficacy of the non-invasive images in the diagnosis of NAFLD. [Time Frame: Baseline (preoperatively), 1 year and 5 years postoperatively.] [Designated as safety issue: Yes]
– Magnetic Resonance Studies.
– Fibroscan.
– Ultrasound.
Sponsors and Collaborators: King Saud University
ClinicalTrials.gov Identifier: NCT01619215

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