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 : Unknown
Verified March 2021 by Medality Medical.
Recruitment status was: Recruiting
First Posted : May 17, 2019
Last Update Posted : March 18, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Insulin Resistance||Device: HydraSolve T2D™||Not Applicable|
|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)|
|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|
|Actual Study Start Date :||October 18, 2019|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||March 15, 2022|
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.
- 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
- 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
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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|
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.)
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.
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.
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
|Contact: Mark Andrew, MD||856-701-2680||Mark.Andrew@MedalityMedical.com|
|United States, Texas|
|University of Texas Health Science Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Ralph A DeFronzo, MD 210-567-6691 email@example.com|
|Contact: Monica Palomo, BS 210-567-6710 firstname.lastname@example.org|
|Principal Investigator: Ralph A DeFronzo, MD|
|Sub-Investigator: Richard Peterson, MD|
|Sub-Investigator: Eugenio Cersosimo, MD PhD|
|Sub-Investigator: Carolina Solis-Herrera, MD|
|Sub-Investigator: Alberto Chavez-Velasquez, MD|
|Sub-Investigator: Mohamed Eletrebi, MD|
|Sub-Investigator: Curtiss Puckett, PA|
|Sub-Investigator: Andrea Hansis-Diarte, MPH|
|Sub-Investigator: Sara Olivarri, BSN|
|Principal Investigator:||Ralph DeFronzo, MD||University of Texas|
|Study Director:||Mark Andrew, MD||Medality Medical|
|Responsible Party:||Medality Medical|
|Other Study ID Numbers:||
|First Posted:||May 17, 2019 Key Record Dates|
|Last Update Posted:||March 18, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||The research team will send deidentified study results to Medality Medical|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Mesenteric Visceral Fat
Type 2 diabetes
Noninsulin-Dependent Diabetes Mellitus
Glucose Metabolism Disorder
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases