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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 : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Medality Medical

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Insulin Resistance Device: HydraSolve T2D™ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Official Title: 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953963


Contacts
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Contact: Mark Andrew, MD 856-701-2680 Mark.Andrew@MedalityMedical.com
Contact: Edward Gillen 201-783-9355 Edward.Gillen@MedalityMedical.com

Locations
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United States, Texas
University of Texas Health Science Center at San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Ralph A DeFronzo, MD    210-567-6691    defronzo@uthscsa.edu   
Contact: Monica Palomo, BS    210-567-6710    palomom@uthscsa.edu   
Principal Investigator: Ralph A DeFronzo, MD         
Sponsors and Collaborators
Medality Medical
Investigators
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Principal Investigator: Ralph DeFronzo, MD University of Texas

Publications:
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Responsible Party: Medality Medical
ClinicalTrials.gov Identifier: NCT03953963     History of Changes
Other Study ID Numbers: CIP-00001
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research team will send deidentified study results to Medality Medical

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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

Keywords provided by Medality Medical:
Mesenteric Visceral Fat
Insulin Resistance
Diabetes
Type 2 diabetes
Diabetes Mellitus
Noninsulin-Dependent Diabetes Mellitus
Glucose Metabolism Disorder
Obesity
Diabesity
HydraSolve T2D

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism