Cinnamomum Cassia Effect on IGF1 and Metabolic Control in Patients With DM2 Without Glycemic Control Metformin Treated (CICAFAC1)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus Type 2, IGF1, Cinnamomum cassia, Metabolic control, Metformin
Eligibility Criteria
Inclusion Criteria:
- Signature of consent under written information prior to the completion of any procedure in the study.
- Men and women aged 40 to 59 years old, residents of Guadalajara, Jalisco and the metropolitan area.
- Ability to communicate and meet all the requirements of the study.
- BMI less than or equal to 34.9 kg / m2.
Diagnosis of DM2 according to the ADA:
- Plasmatic glucose ≥126mg / dl (7.0 mmol / L) in an 8-hour fast.
- Plasmatic glucose ≥200mg / dl (11.1 mmol / L) at 2 hours after an oral glucose tolerance test.
or HbA1C ≥6.5% (48 mmol / mol).
o Plasmatic glucose ≥200mg / dl (11.1 mmol / L) in a random sample to the patient with classic symptoms of hyperglycemia.
- Evolution of DM2 less than 1 year.
- Be receiving pharmacological treatment with metformin in doses less than or equal to 850mg.
- Stable body weight within 3 months prior to the start of the study, defined as a variability in body weight of less than 10%.
- Eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment.
Exclusion Criteria:
- Determination of HbA1c less than 6.5%, greater than 10% or fasting glucose greater than 250 mg / dL.
- Serum total cholesterol concentration greater than or equal to 240mg / dl.
- Serum triglyceride concentration greater than or equal to 400mg / dl.
- History of hypersensitivity to study drugs.
- Intake of drugs with known effects on glucose metabolism, lipids, and weight.
- Uncontrolled arterial hypertension, defined as systolic blood pressure values greater than or equal to 140mm / Hg and a diastolic blood pressure greater than or equal to 90mm / Hg.
- History of cardiovascular disease, blood disorders, kidney, pancreatic or thyroid disease.
- Women with suspicion or confirmation of pregnancy
- Women in breastfeeding period.
- History of smoking at any intensity within 12 months prior to the start of the study.
- History of drug abuse or alcoholism.
- Inability to attend or answer the evaluations made in each of the visits.
- Pacemaker bearing, or any other permanent bioelectronic element that can modify the electric bioimpedance reading or be affected by it.
Sites / Locations
- Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Cinnamomum Cassia
Placebo
A group of 14 patients (7 women and 7 men) with DM2 without adequate control, treated with metformin 850mg daily, who will receive 1g of cinnamomum cassia orally every 8 hours, for 90 days.
A group of 14 patients (7 women and 7 men) with DM2 without adequate control, treated with metformin 850mg daily, who will receive 1g of placebo (calcined magnesia) orally every 8 hours, for 90 days.