Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder characterized by
insulin resistance and beta-cell dysfunction. Current therapeutic approaches primarily
aim to improve insulin sensitivity and glycemic control but do not restore pancreatic
beta-cell function or incretin signaling.
The duodenum plays a central role in metabolic signaling and insulin sensitivity
regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may
improve glycemic control.
Adipose-derived mesenchymal stem cells (ADSCs), obtained from stromal vascular fraction
(SVF), have demonstrated immunomodulatory and regenerative properties. The One-STEP™
selective tissue engineering photostimulation technique (1210-nm diode laser) enables
preservation of adipocytes and ADSCs without enzymatic digestion, maintaining high cell
viability and surface marker expression.
In this study, 40 mL of abdominal subcutaneous adipose tissue will be harvested using
laser-assisted photochemical stimulation (Medilaser S 1210 nm). The lipoaspirate will
undergo double centrifugation (800g and 700g) to isolate SVF without collagenase. The
resulting pellet will be injected into the duodenal submucosa during the same procedure.
Participants will be monitored for six months with metabolic and quality of life
assessments.
Kaiser Clinic and Hospital
1Research sites
10Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Age ≥ 18 years.
Both sexes.
Diagnosis of Type 2 Diabetes Mellitus for less than 10 years.
BMI ≥ 25 kg/m².
HbA1c between 7.5% and 9.5%.
C-peptide > 1.0 nmol/L.
Use of metformin and/or pioglitazone, with or without sulfonylurea.
Type 1 Diabetes Mellitus or autoimmune diabetes.
Positive anti-GAD antibodies.
Pregnancy or breastfeeding.
Use of insulin therapy.
Use of SGLT2 inhibitors.
Use of DPP-4 inhibitors.
Use of GLP-1 receptor agonists.
Unknown duration of diabetes.
Sites
Kaiser Clínica
Recruiting
R. XV de Novembro, 3975 - Vila Redentora, São José do Rio Preto - SP, 15015-110