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

NCT03953963 | Unknown DMC FDA Device

• 1 other identifier: CIP-00001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 30-39.9 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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

Mesenteric Visceral Fat; Insulin Resistance; Diabetes; Type 2 diabetes; Diabetes Mellitus; Noninsulin-Dependent Diabetes Mellitus; Glucose Metabolism Disorder; Obesity; Diabesity; HydraSolve T2D

Outcome Measures

Primary Outcomes (2)

• Change in blood glucose control

  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.

  6 and 12 months after the procedure

• Lack of serious adverse events (SAEs)

  Lack of serious adverse events (SAEs) assessed continuously during or after the procedure

  Through 1 year study completion

Secondary Outcomes (4)

• Change in Insulin Sensitivity

  6 and 12 months after the procedure

• Change in blood glucose control

  1-week, 3, 6, and 12-months post procedure

• Change in fasting plasma glucose (FPG)

  1, 3, 6, and 12-month post procedure

• Reduction in body weight

  1, 2, 3, 4, 10, 12, 18 weeks, and 6, 8, 10, 12 months post procedure

Study Arms (1)

Intra-Abdominal Mesenteric Fat Extraction Group

EXPERIMENTAL

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™

Interventions

HydraSolve T2D™ DEVICE

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.

Intra-Abdominal Mesenteric Fat Extraction Group

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willingness to provide written informed consent.
• \. 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.
• \. Male or female between 22 - 75 years of age. (Caveat: premenopausal women are excluded)
• \. 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.
• \. BMI 30 to 39.9 kg/m2.
• \. 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.)
• \. Diagnosis of T2D 10 years or less in duration.
• \. 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.
• \. HbA1c: 8.0 % - 10.0 %, taken within 30 days pre-op.
• \. Subjects receiving exogenous thyroid hormone, a euthyroid status for at least 3 months prior to enrollment needs to be documented.
• \. Subject agrees to not take any medications that can influence glycemic control unless directed to do so specifically by their physician.
• \. Subject agrees to report all medications they are taking on all case report forms.
• \. Subject agrees to not take any herbal or dietary supplements during the study period.
• \. Subject agrees to not donate blood during the study period.
• \. Subject resides in the San Antonio, TX geographic area.

You may not qualify if:

• \. Premenopausal females.
• \. Tobacco use.
• \. Current drug or ETOH abuse.
• \. Uncontrolled psychiatric illness.
• \. Abnormal T4 and TSH found in screening blood test.
• \. Subjects who have contraindications to major abdominal surgery are excluded.
• \. Serum albumin \<35 g/L
• \. Body weight loss \>5% during the 6 month time period preceding the anticipated surgery date.
• \. Presence of a remote body site infection. (Examples: dental urinary, skin soft tissue)
• \. History of cholecystitis, hepatitis or NASH.
• \. History of ulcerative colitis, Crohn's disease, or diverticulitis.
• \. History of respiratory conditions that are not controllable without the use of chronic or intermittent steroid use; such as poorly controlled asthma or COPD.
• \. 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.)
• \. LDL ≥ 180 mg/dl.
• \. Triglycerides ≥ 400 mg/dl.

Sponsors & Collaborators

• Medality Medical: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 29631983 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Diabetes Mellitus; Glucose Metabolism Disorders; Obesity; Diabesity

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications

Study Officials

• Ralph DeFronzo, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Mark Andrew, MD

  Medality Medical

  STUDY DIRECTOR

Central Study Contacts

Mark Andrew, MD

CONTACT

856-701-2680; Mark.Andrew@MedalityMedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 17, 2019
• Study Start: October 18, 2019
• Primary Completion: July 30, 2021
• Study Completion: March 15, 2022
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)