Clinical Trials in Bariatric and Metabolic Medicine

| April 1, 2017

Fecal Microbiota Transplantation for the Treatment of Obesity (FMT Obesity)
Status: This study is currently recruiting participants.
Purpose: This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Eligibility:
•    Ages Eligible for Study: 18 Years and older (Adult, Senior)
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: No
Criteria:
Inclusion Criteria:
-Age 18 years or older
-Obesity defined as a BMI of 35kg/m2 or higher
Exclusion Criteria:
-Triglycerides > 500 mg/dL
-Use of antibiotics <8 weeks prior to participation
-Use of probiotics <4 weeks prior to participation
-Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
-Substance abuse, current
-LFTS greater then 3x the ULN
-Cirrhosis.
-DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C > 10%)
-Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
-History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months
-Patients who are pregnant or breastfeeding
-Patients who are unable to give informed consent
-Patients who have previously undergone FMT
-Patients who have a confirmed malignancy or cancer
-Patients who are immunocompromised
-Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
-Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy
-Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
-History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia
-Any condition, based on clinical judgment that may make study participation unsafe
-History of severe food allergies
-Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11
-Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide
-Congenital or acquired immunodeficiencies
Primary Outcome Measures:
•    Safety of fecal microbiota transplantation (FMT) as measured by number and nature of adverse events within 52 weeks of FMT [ Time Frame: 1 year ]
•    Adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation patient administered a biologic product. It is an unintended sign, symptom, or disease temporally associated with the use of the investigational agent. Adverse events will be determined by a toxicity grading scale.
Sponsors and Collaborators:
•    Brigham and Women’s Hospital, Boston, Massachusetts
ClinicalTrials.gov identifier: NCT02741518

Physical Activity, Sedentary and Energy Consumption After Bariatric Surgery
Status: This study is currently recruiting participants.
Purpose: This study aims to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.
Study Type: Observational
Study Design:
Observational Model: Case-Only
Time Perspective: Prospective
Eligibility:
•    Ages Eligible for Study: Child, Adult, Senior
•    Sexes Eligible for Study: All
•    Accepts Healthy Volunteers: No
•    Sampling Method: Non-Probability Sample
•    Study Population: Patients undergoing bariatric surgery
Criteria:
Inclusion Criteria:
-All patient at Lindesbergs hospital that get bariatric surgery (a limit to get the surgery is BMI above 35)
Exclusion Criteria:
-Not understanding Swedish or English
-Not the first bariatric surgery
Primary Outcome Measures:
•    Calories consumed [Time Frame: one year after surgery]
Amount calories consumed per day
•    Hours sedentary [Time Frame: one year after surgery ]
Hours sedentary during a day
Secondary Outcome Measures:
•    Mediators of physical activity [Time Frame: one year after surgery]
•    Self-efficacy, social support, and enjoyment of physical activity measured by questionaires
Sponsors and Collaborators: Region Örebro County, Örebro, Sweden
ClinicalTrials.gov identifier: NCT02938338

Effects of Alcohol After Bariatric Surgery (RBA)
Status: This study is not yet open for participant recruitment.
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
Study Design:
Observational Model: Other
Time Perspective: Other
Eligibility:
•    Ages Eligible for Study: 21 Years to 65 Years (Adult)
•    Sexes 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
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 9 months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.]
•    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 9 months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.]
•    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 9 months after bariatric surgery [Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.]
Sponsors and Collaborators:
•    University of Illinois at Urbana-Champaign
•    University of Missouri-Columbia
•    Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01843257

An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH (IIH:WT)
Status: This study is currently recruiting participants.
Purpose: This trial aims to compare two methods of weight loss, bariatric surgery and the most effective dietary programme commonly available, Weight Watchers, to see which offers the most effective sustainable treatment for idiopathic intracranial hypertension (IIH). Bariatric surgery is recommended by the NICE clinical guidelines for patients with a body mass index (BMI) of over 40kg/m2, or over 35kg/m2 with a co-morbidity. Women suffering from IIH have a BMI on average around 38kg/m2 and IIH is not recognized as a co-morbidity for bariatric surgery.

This trial will recruit 60 women with IIH from the Queen Elizabeth Hospital Birmingham, a major UK IIH centre. They will be randomized and 30 participants will be allocated to the dietetic intervention arm, and be enrolled in their local Weight Watchers group. Thirty participants will be allocated to the bariatric surgery arm, and will be referred to the Birmingham Heartlands Hospital bariatric surgery pathway to receive bariatric surgery. Both groups of participants will be allocated to a treatment arm which is proven to bring about weight loss.

Participants will then be followed up for five years, with the most important measurement being their brain pressure after one year of being in the trial.
A further 20 women with obesity who don’t suffer from IIH will be recruited to compare the baseline symptoms and biomarkers of those with IIH; they will take no further part in the study. Five further healthy individuals will be scanned twice in an MRI test group to validate the MRI scan sequence to be used in the trial.
Study Type: Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Eligibility:
•    Criteria
Inclusion Criteria:
-Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (> 6 months duration), active disease (papilloedema [Frisen grade ≥ 1], significantly raised ICP > 25cmH2O) and no evidence of venous sinus thrombosis (magnetic resonance or CT imaging and venography as noted at diagnosis).
-BMI >35kg/m2.
-Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
-Able to give informed consent.
Exclusion Criteria:
-Age less than 18 or older than 55 years.
-Pregnant or planning to conceive during the first 18 months of the trial
-Significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
-Undergone optic nerve sheath fenestration.
-Definite indication for or contraindication against surgery or dieting.
-Have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months).
-Previous bariatric surgery.
-Taken AZD4017 within the last four months .
-Inability to give informed consent (e.g., due to cognitive impairment).
Primary Outcome Measures:
•    Intracranial Pressure [Time Frame: 12 months] Change in Intracranial Pressure (ICP) between baseline and 12 months.
-ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.
Secondary Outcome Measures:
•    Intracranial Pressure [Time Frame: 60 months]
•    Change in ICP between baseline and 24 and 60 months.
-ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.
•    IIH symptoms [Time Frame: 12 months]
-Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months)
•    Visual function [Time Frame: 12 months]
-Change in visual function from 0 to 12 months (and at 24 and 60 months). Assessments to be undertaken are the LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation, an evaluation of contrast sensitivity and an Ishihara book to assess colour vision. The pupils will then be dilated using 1% tropicamide. Papilloedema will then be measured using spectral optical coherence tomography. Papilloedema will be further graded following fundus photographs. This will be done after all participants have reached the primary endpoint by two neuro-ophthalmologists blinded to trial treatment arm. The assessors will score the paired papilloedema images as better/same/worse as per the methodology described in a previous study. They will also assign a Frisen score to the images.
•    Papilloedema [Time Frame: 12 months]
-Change in papilloedema from 0 to 12 months (and at 24 and 60 months)
•    Headache [ Time Frame: 12 months]
-Change in headache associated disability from 0 to 12 months (and at 24 and 60 months). Headache will be assessed by participant completed questionnaires. Participants will complete a daily headache diary in the week before assessments, which will evaluate the Headache Index score and use of analgesia (days/week). Headache associated disability will be evaluated using the Headache Impact Test-6 score (HIT 6). Severity and frequency of headaches will be assessed retrospectively using the Headache Index. Headache phenotype (according to criteria from the International Headache Society) will also be assessed.
•    Anthropological measures [Time Frame: 12 months]
-Change in anthropological measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months)
•    Quality of Life [Time Frame: 12 months]
-Change in quality of life (participant reported) from 0 to 12 months (and at 24 and 60 months)
•    Referrals to CSF shunting procedures and optic nerve sheath fenestration [ Time Frame: 12 months ]
-Difference in number of referrals to cerebrospinal fluid (CSF) shunting procedures and optic nerve sheath fenestration between treatment arms at 0 to 12 months (and at 24 and 60 months)
•    Health Economics [ Time Frame: 12 months ]
-Health economics including cost-effectiveness at 12, 24 and 60 months.
Sponsors and Collaborators:
•    University of Birmingham
•    National Institute for Health Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02124486  

Tags: , ,

Category: Past Articles, Research Bites

Comments are closed.