Is NCT04101669 recruiting in Boston, MA?

Yes, NCT04101669 is currently recruiting participants at its Boston, MA location. This diabetes type2 clinical trial is actively enrolling qualified participants.

How do I join the diabetes type2 clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetes type2 Clinical Trial in Boston, MA

About This Diabetes type2 Study in Boston

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).

Sponsor: Morphic Medical Inc.

Who Can Participate

Inclusion Criteria

Age ≥22 years and ≤ 65 years

Have understood and signed the approved informed consent form

Diagnosis of type 2 diabetes

HbA1c ≥ 7.5% and ≤10%

BMI ≥30kg/m2 and ≤ 50kg/m2

Willing and able to comply with study requirements

Documented negative pregnancy test in women of childbearing potential

Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies

At least one year of medical records available, including detailed medical therapy and dosing information

Failed to achieve adequate HbA1c reduction (\<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.

Exclusion Criteria

Previous treatment with the RESET System

Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner

Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance

Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)

eGFR of less than 45 ml/min/1.73 m2

Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage

Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement

Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis

Fasting C-peptide \< 1.0 ng/mL

Triglyceride level \> 600 mg/dL

Vitamin D deficiency (\<20ng/ml)

Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy

Height \< 5 feet (152.4 cm)

Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers

History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)

Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide

Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)

Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.

Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4)

Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 9 months post implant procedure

Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure: Restricted Medications/Supplements Systemic corticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide) Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics) Supplements that are known or suspected to increase bleeding risk including but not limited to: Gingko biloba Ginseng Vitamins C \& E Turmeric St. John's wort Evening primrose oil Feverfew Green Tea Extract

Active H. pylori

History of Crohn's disease, atresias or untreated stenoses

Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization

Patients may be disqualified for study inclusion for any condition determined by the PI that places the patient at undue risk

Poor dentition not allowing complete chewing of food

Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)

Residing in a location without ready access to study site medical resources

Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization

Positive Fecal Immunochemical Test (FIT) at time of screening

History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan

No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary

Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study

Any condition that increases red cell turnover, such as thalassemia

Existence of (\>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2

A known sensitivity to nickel or titanium

Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)

Patients with history or suspicion of coronary artery disease

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04101669) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetes type2 Treatment Options in Boston, MA

If you're searching for diabetes type2 treatment options in Boston, MA, this clinical trial (NCT04101669) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetes type2 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetes type2 clinical trials near you to find additional studies recruiting in your area.

Diabetes type2 Clinical Trial in Boston, MA

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