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Lay Description

The purpose of this research study is to determine if removing about 75% of the mesenteric visceral fat located in the mesentery adjacent to the small bowel will reverse insulin resistance, cause a significant improvement in the glycemic control of your type 2 diabetes, and cause you to lose weight. This surgical procedure is called Mesenteric Visceral Lipectomy (MVL).

Category

  • Diabetes
IRB Number
20190076HU
NCT Number
NCT03953963
Open to Enrollment
Yes

Eligibility

Eligible Ages
22 - 75
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. BMI 30 to 35 kg/m2.
  2. Stable body weight during the 6 month time period preceding the anticipated surgery date. (Stable is defined as: the usual baseline body weight of the subject +/- < 5% change.)
  3. Diagnosis of T2D 5 years or less in duration.
  4. Subject has poorly controlled T2D and is on a current regimen of at least two oral hypoglycemic agents, the first medication dosed at the maximum dose, and the second dosed at the minimum or higher labelled dose.  Subject’s treatment regime does not include insulin treatment.
  5. HbA1c: 8.0 % – 10.0 %, taken within 30 days pre-op.
  6. Subjects receiving exogenous thyroid hormone, a euthyroid status for at least 3 months prior to enrollment needs to be documented.
  7. Subject resides in the San Antonio, TX geographic area.
  8. Subject is able to have MRI examinations.

Exclusion Criteria

  1. Premenopausal females.
  2. Tobacco use.
  3. Current drug or ETOH abuse.
  4. Uncontrolled psychiatric illness.
  5. Abnormal T4 and TSH found in screening blood test.
  6. Subjects who have contraindications to major abdominal surgery are excluded.
  7. Serum albumin <35 g/L
  8. Body weight loss >5% during the 6 month time period preceding the anticipated surgery date.
  9. Presence of a remote body site infection.  (Examples: dental  urinary, skin soft tissue)
  10. History of cholecystitis, hepatitis or NASH
  11. History of ulcerative colitis, Crohn’s disease, or diverticulitis.
  12. History of respiratory conditions that are not controllable without the use of chronic or intermittent steroid use; such as poorly controlled asthma or COPD.
  13. Chemistry, liver enzyme and function, and hematology levels that are outside of the normal range. (Fasting glucose may be elevated but subject will be excluded if it is = 250 mg/dl.)
  14. LDL = 180 mg/dl
  15. Triglycerides = 400 mg/dl.
  16. A diagnosis of Cushing’s disease. (If a potential subject does not have a diagnosis of Cushing’s disease, and the examining endocrinologist detects concerning signs or symptoms that lead him/her to suspect that the potential subject may have Cushing’s disease (based on the subject’s history, review of systems and physical exam) then that potential subject will be excluded from the study and referred back to his/her primary care physician for further evaluation.)
  17. Anemia, hemoglobinopathy or any conditions that increase red blood cell turnover.
  18. Recent history of receiving a blood transfusion.
  19. Recent history of donating blood.
  20. Clinically significant major organ disease as determined by medical history, physical exam, screening blood tests, urinalysis, and EKG.
  21. History of prior abdominal/pelvic surgery, or prior OB/GYN surgery.
  22. Uncontrolled comorbidity. (Example: uncontrolled hypertension.)
  23. Large umbilical hernia. (This does not include small umbilical hernias that are fat containing only; subjects with this specific type of hernia are allowed in the study, and this type of hernia could be managed and closed primarily with closure of the surgical site.)
  24. Large ventral hernia.
  25. Use of insulin.
  26. Anticoagulation or antiplatelet therapies.
  27. History of gastrointestinal cancer.
  28. Limited life expectancy.

Study Design

An interventional study using an investigatonal device. The study has a single group of participants who are assigned to the treatment. 

Study Contact

Regulatory Point of Contact
Andrea Hansis-Diarte
+1 (210) 567-3208
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Christina Agyin
2103587200
agyin@uthscsa.edu

Principal Investigator
Ralph Defronzo