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Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03953963
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medality Medical

Tracking Information
First Submitted Date  ICMJE May 12, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date August 26, 2019
Estimated Study Start Date  ICMJE August 23, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Change in blood glucose control [ Time Frame: 6 and 12 months after the procedure ]
    Change in blood glucose control, as measured by the average of two HbA1c values at 6-months and 12-months post-procedure and at other time points, compared to the average of two HbA1c values 1-month pre-procedure.
  • Lack of serious adverse events (SAEs) [ Time Frame: Through 1 year study completion ]
    Lack of serious adverse events (SAEs) assessed continuously during or after the procedure
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Change in glycemic control [ Time Frame: 6 and 12 months after the procedure ]
Change in glycemic control as measured by the average of the two HbA1c values at 6 months and at 12 months post-op compared to the average of the two HbA1c values at 1 month before surgery (Aiming for an improvement of 1.2 %, or greater.)
Change History Complete list of historical versions of study NCT03953963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Change in Insulin Sensitivity [ Time Frame: 6 and 12 months after the procedure ]
    Change in insulin sensitivity as measured by hyperinsulinemic euglycemic clamp at 6 and 12 months, as compared to pre-procedure
  • Change in blood glucose control [ Time Frame: 1-week, 3, 6, and 12-months post procedure ]
    Change in blood glucose control (time in range, etc.) as measured by Continuous Glucose Monitoring (CGM) pre-procedure, and at 1-week, 3, 6 and 12-months post procedure
  • Change in fasting plasma glucose (FPG) [ Time Frame: 1, 3, 6, and 12-month post procedure ]
    Change in fasting plasma glucose (FPG) and mean glycemic excursion as measured by oral glucose tolerance test (OGTT) pre-procedure and 1, 3, 6 and 12-months post procedure
  • Reduction in body weight [ Time Frame: 1, 2, 3, 4, 10, 12, 18 weeks, and 6, 8, 10, 12 months post procedure ]
    Reduction in body weight measured at each clinic visit
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Change in Insulin Sensitivity [ Time Frame: 6 and 12 months after the procedure ]
Change in insulin sensitivity, as measured by the hyperinsulinemic euglycemic clamp rate of glucose disposal ("Rd") (average of) at 6 months and at 12 months post-op compared to the pre-op clamp Rd (average of) performed 1 week before the MVL procedure. (Aiming for an improvement in the average Rd of 33%, or greater.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes
Official Title  ICMJE Evaluation of the Removal of Excess Intra-Abdominal Fat in Subjects With Type 2 Diabetes and Obesity, Using the HydraSolve T2D™ System, on Glucose Control, Insulin Resistance and Body Weight
Brief Summary This study will investigate the safety and efficacy of the investigational use of the HydraSolve T2D™ System in improving blood glucose control and insulin resistance in patients with obesity (Class 1, BMI 30-35 kg/m2) and type 2 diabetes who have not achieved targeted levels of blood glucose control using oral diabetes medications. The previously FDA-cleared (for liposuction and fat transfer) HydraSolve T2D™ System will be used to perform a novel, minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove excess intra-abdominal fat from the mesentery (Mesenteric Visceral Lipectomy (MVL)), while not affecting surrounding tissues. The study will include several weeks of screening for eligibility before the intervention, and 12-months of follow-up post-surgery.
Detailed Description This study will evaluate the investigational use of the HydraSolve T2D™ System (previously FDA-cleared for liposuction and fat transfer) to perform a novel, minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove intra-abdominal fat from the mesentery and to assess the resulting changes in blood glucose control, insulin sensitivity and body weight. Excess intra-abdominal mesenteric fat has been directly linked to insulin resistance, an important precursor of type 2 diabetes. Up to 30 study candidates will undergo screening and eligibility testing over a 5-week period from which 12 will be enrolled to undergo the procedure. During the 12-month period post-procedure, the patients will be periodically monitored for improvements in blood glucose control (HbA1c, oral glucose tolerance test (OGTT), fasting blood glucose (FBG) and continuous glucose monitoring (CGM)), insulin resistance (hyperinsulinemic euglycemic glucose clamp), body weight, changes in fat deposits (Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) and Dual-Energy X-ray Absorptiometry (DEXA)) and overall metabolic health (including indirect calorimetry and various biomarkers). This prospective, single-arm study uses pre-operative patient data as the control. Safety assessments and monitoring for adverse events will be performed, throughout.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Patients will be experimental subjects, they will serve as their own controls by comparing their pre-op status to their post-op status in the parameters of investigation which include insulin status assessment (resistance versus sensitivity, as determined by hyperinsulinemic euglycemic clamp), measurements of glycemic control of T2D, and body weight measurements.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Insulin Resistance
Intervention  ICMJE Device: HydraSolve T2D™
The HydraSolve T2D™ System will be used to perform the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery. All patients will receive standard nutritional counseling and their medications will be adjusted to achieve target levels of blood glucose control.
Study Arms  ICMJE Experimental: Intra-Abdominal Mesenteric Fat Extraction Group
All enrolled patients will undergo the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery.
Intervention: Device: HydraSolve T2D™
Publications * Andrew MS, Huffman DM, Rodriguez-Ayala E, Williams NN, Peterson RM, Bastarrachea RA. Mesenteric visceral lipectomy using tissue liquefaction technology reverses insulin resistance and causes weight loss in baboons. Surg Obes Relat Dis. 2018 Jun;14(6):833-841. doi: 10.1016/j.soard.2018.03.004. Epub 2018 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
30
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Willingness to provide written informed consent.

    2. Willingness and availability to comply with study requirements for the duration of the study, including specific inquiry that the potential subject does not have an impending move or travel planned and can attend the patient visits without undue hardship.

    3. Male or female between 22 - 75 years of age. (Caveat: premenopausal women are excluded)

    4. In good general health except for being diagnosed as having T2D,and in good enough general health to undergo a conversion from a mini-laparotomy to an open laparotomy incision if that conversion becomes necessary during the operative procedure; the subject has no major system disease other than T2D as determined by physical examination, medical history, screening laboratory tests, and EKG.

    5. BMI 30 to 35 kg/m2.

    6. 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.)

    7. Diagnosis of T2D 5 years or less in duration.

    8. 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.

    9. HbA1c: 8.0 % - 10.0 %, taken within 30 days pre-op.

    10. Subjects receiving exogenous thyroid hormone, a euthyroid status for at least 3 months prior to enrollment needs to be documented.

    11. Subject agrees to not take any medications that can influence glycemic control unless directed to do so specifically by their physician.

    12. Subject agrees to report all medications they are taking on all case report forms.

    13. Subject agrees to not take any herbal or dietary supplements during the study period.

    14. Subject agrees to not donate blood during the study period.

    15. Subject resides in the San Antonio, TX geographic area.

    16. 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 ≥ 200 mg/dl.)

    14. LDL ≥ 130 mg/dl.

    15. Triglycerides ≥ 200 mg/dl.

    16. Total cholesterol ≥ 225 mg/dl.

    17. HDL < 40 mg/dl for males; < 50 mg/dl females

    18. 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.)

    19. Anemia, hemoglobinopathy or any conditions that increase red blood cell turnover.

    20. Recent history of receiving a blood transfusion.

    21. Recent history of donating blood.

    22. Clinically significant major organ disease as determined by medical history, physical exam, screening blood tests, urinalysis, and EKG.

    23. History of prior abdominal/pelvic surgery, or prior OB/GYN surgery.

    24. Uncontrolled comorbidity. (Example: uncontrolled hypertension.)

    25. 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.)

    26. Large ventral hernia.

    27. Use of insulin.

    28. Anticoagulation or antiplatelet therapies.

    29. History of gastrointestinal cancer.

    30. Limited life expectancy.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Andrew, MD 856-701-2680 Mark.Andrew@MedalityMedical.com
Contact: Edward Gillen 201-783-9355 Edward.Gillen@MedalityMedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953963
Other Study ID Numbers  ICMJE CIP-00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The research team will send deidentified study results to Medality Medical
Responsible Party Medality Medical
Study Sponsor  ICMJE Medality Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ralph DeFronzo, MD University of Texas
PRS Account Medality Medical
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP