A Study to Evaluate the Effect of POSE2 on Long-term Gastric Motor Function

Overview

About this study

The purpose of this study is to explore the effectiveness and safety of a modified gastroplication technique for weight loss in five patients with obesity, and includes physiologic appraisal of gastric emptying (via gastric emptying breath test) and post-prandial gastric accommodation (via SPECT).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adults who are receiving the POSE2 as part of the main study on POSE2 safety and feasibility (IRB 19-001254).  Inclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the addition that they must be able to safely undergo non-contrasted MRI testing.

  • Provision of signed and dated informed consent form.
  • Subject agrees to be compliant with study requirements and adhere to post-operative dietary & exercise recommendations for the duration of the study.
  • Subjects between the ages of 22-60 years old.
  • If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
  • Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)).
  • Pre-diabetes – Fasting plasma glucose test > 100 mg/dl but ≤ 125 or oral glucose tolerance test ≥ 140 mg/dl but < 200.
  • Diabetes – Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose > 126 mg/dl.
  • Hypertension – SBP >140 or DBP > 90 or the use of an antihypertensive medication.
  • Dyslipidemia – Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications.
  • Sleep Apnea – A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
  • Venous Stasis Disease – Presence or history of pretibial venous stasis ulcers.
  • Chronic Joint Disease – Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
  • Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
  • Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  • Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
  • Subjects must be willing to possibly forego any future weight loss procedures (i.e., Vertical Sleeve Gastrectomy) given the unknown long-term effects.
  • Residing within a reasonable distance from the Investigator’s treating office (~50 miles) and willing and able to travel to the Investigator’s office to complete all routine follow-up visits.
  • Must be able to safely undergo non-contrasted MRI testing.

Exclusion Criteria: 

Exclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the additional exclusion of patients who cannot safely undergo non-contrasted MRI.

  • History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  • Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
  • Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
  • Large hiatal hernia (> 3 cm) by history or as determined by pre-enrollment endoscopy.
  • Pancreatic insufficiency/disease.
  • History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
  • Pregnancy or plans of pregnancy in the next 12 months.
  • History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
  • Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
  • Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
  • History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
  • Active gastric erosion, lesion, or gastric/duodenal ulcer.
  • History of or current platelet or coagulation dysfunction, such as hemophilia.
  • History or present use of insulin or insulin derivatives for treatment of diabetes.
  • Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.
  • If smoker, plans to quit smoking in the year after enrollment.
  • Portal hypertension and/or varices.
  • Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  • Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
  • Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
  • Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI).
  • Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes.
  • Non-ambulatory or has significant impairment of mobility (i.e., cannot ambulate for 30 minutes).
  • Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  • Participating in another clinical study.
  • Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
  • Physician’s assessment that the subject is not an appropriate candidate.
  • Subjects who are unable to safety undergo or who would not tolerate non-contrasted MRI.
  • 1If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution’s standard procedure.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Open for enrollment

Contact information:

Erik Hyland

(507)284-4723

Hyland.Erik@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20470195

Mayo Clinic Footer