Diabetes Mellitus, Type 2NCT03953963
Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes
A study testing HydraSolve T2D™ in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Medality Medical at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- HydraSolve T2D™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 39.9 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.)
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- 7. Diagnosis of T2D 10 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Ralph A DeFronzo, MD, 210-567-6691, defronzo@uthscsa.edu
Monica Palomo, BS, 210-567-6710, palomom@uthscsa.edu
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- HydraSolve T2D™
- Keywords
- Mesenteric Visceral Fat, Insulin Resistance, Diabetes, Type 2 diabetes, Diabetes Mellitus, Noninsulin-Dependent Diabetes Mellitus, Glucose Metabolism Disorder, Obesity, Diabesity, HydraSolve T2D
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Mellitus, Glucose Metabolism Disorders, Obesity, Diabesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HydraSolve T2D™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through 1 year study completion
Secondary outcomes (4)
Change in Insulin Sensitivity
Change in insulin sensitivity as measured by hyperinsulinemic euglycemic clamp at 6 and 12 months, as compared to pre-procedure
Measured: 6 and 12 months after the procedure
Change in blood glucose control
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
Measured: 1-week, 3, 6, and 12-months post procedure
Change in fasting plasma glucose (FPG)
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
Measured: 1, 3, 6, and 12-month post procedure
Reduction in body weight
Reduction in body weight measured at each clinic visit
Measured: 1, 2, 3, 4, 10, 12, 18 weeks, and 6, 8, 10, 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start18 Oct 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medality Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph DeFronzo, MD, Principal investigator, University of TexasMark Andrew, MD, Study director, Medality Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953963
- Sponsor's protocol ID
- CIP-00001
- Status last verified
- Mar 2021
- First submitted
- 12 May 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The research team will send deidentified study results to Medality Medical
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.
PubMed 29631983
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03953963
- Acronym / sponsor ID
- CIP-00001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medality MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intra-Abdominal Mesenteric Fat Extraction Group | Experimental | Device: HydraSolve T2D™All enrolled patients will undergo the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 39.9 kg/m2.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intra-Abdominal Mesenteric Fat Extraction Group |
Primary outcome
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
4 secondary outcomes
Change in Insulin Sensitivity
Time frame: 6 and 12 months after the procedure
Change in blood glucose control
Time frame: 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
Reduction in body weight
Time frame: 1, 2, 3, 4, 10, 12, 18 weeks, and 6, 8, 10, 12 months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 29631983Andrew 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.
- Individual participant dataSharing planned: No. The research team will send deidentified study results to Medality Medical
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph DeFronzo, MD principal investigator
University of Texas
Mark Andrew, MD study director
Medality Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HydraSolve T2D™ in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Medality Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Andrew, MD (856-701-2680, Mark.Andrew@MedalityMedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose control (time frame: 6 and 12 months after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.