Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Korábbi kezelés

• Prior surgery with chronic malabsorption (eg, bariatric) within last 1 year
• Chronic use of high dose anti-inflammatory drugs for the last 3 months
• Beginning statin medications or change in statin dose within the past 1 month
• Starting use of high-dose steroid medication (100mg hydrocortisone or 40mg prednisone equivalent) within the last 1 month
• Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration plus 2 months post treatment (for semaglutide washout).
• Chronic or persistent alcohol or drug abuse
• Participation in another trial with an investigational drug within 30 days prior to informed consent.

Más betegség

• Known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months
• Personal or family history of medullary thyroid cancer (MTC)
• Personal or family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
• Clinically significant RBC disorders such as hemoglobinopathies
• Diagnosis of Type 1 diabetes mellitus or history of GAD antibody positive status
• History of acute pancreatitis within the past 2 years
• Known or suspected allergy to GLP-1 agonists, excipients, or related products.
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
• Chronic Kidney Disease (CKD) stage 5 (estimated CrCl less than 15 mL/min)

Laborértékek

• Uncontrolled hyperglycemia with fasting glucose >300 mg/dL (>16.6 mmol/L)
• Liver disease with ALT, AST or ALP ≥ x3 ULN
• GFR <30 mL/min/1.73 m2 by MDRD
• Untreated or active hemorrhagic proliferative diabetic retinopathy
  • Exclusionary Laboratory Findings
• Triglycerides > 500 mg/dL

Egyéb

• Active smokers, >5 per day (at present)
• Women who are pregnant or breastfeeding
• Prisoners or subjects who are involuntarily incarcerated
• Low hematocrit (<28 Units)

• Age 20-90
• Diagnosed with Type 2 diabetes mellitus
• Body Mass Index (BMI) between 25.0-45.0 (both inclusive)
• eGFR ≥ 30 mL/min/1.73 m2 by MDRD
• HbA1C 6.5 - 12.0 %
• Subjects on lifestyle modification alone, or Metformin (0.5-2 grams), insulin, or in combination, in any doses of either Metformin or Insulin for at least 3 months prior to screening. 2 week washout of any other anti-hyperglycemic.
• Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted.
• Additional CVD risk factor such microalbuminuria or proteinuria (as defined by ADA, UACR > 30 mg/g), hypertension (labile, uncontrolled hypertension or controlled on anti-hypertensives) and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or an ankle brachial index [the ratio of the systolic blood pressure at the ankle to the systolic blood pressure in the arm] of less than 0.9, low HDL with hypertriglyceridemia (as defined by NCEP ATP III) , strong family history of CHD (as defined by NCEP ATP III and ATP IV).
• Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy