Cinnamomum Cassia Effect on IGF1 and Metabolic Control in Patients With DM2 Without Glycemic Control Metformin Treated
CICAFAC1
Effect of Cinnamomum Cassia as an Enhancer of the Insulin Response of the Insulin-Like Growth Factor-1 and Metabolic Control in Patients With Type 2 Diabetes Mellitus Treated With Metformin Without Glycemic Control
1 other identifier
interventional
28
1 country
1
Brief Summary
Among the multiple treatment options for Diabetes Mellitus Type 2 (DM2), the influence on Insuline like growth factor 1 (IGF1) plays a causal role in diabetes but has shown similarities with insulin, both in its structure and in its function, including a rapid reduction in glucose levels in blood, could improve glycemic control in patients. Oral administration of 3 g of cinnamomum cassia for 90 days acts as an enhancer of the IGF1 insulin response and on metabolic control (fasting glucose, glycosylated hemoglobin (HbA1c), triglycerides, total cholesterol, high density cholesterol, low density cholesterol, very low density cholesterol, systolic and diastolic blood pressure (TAS and TAD), body weight) in patients with DM2 without glycemic control treated with metformin at doses ≤ 850 mg daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Aug 2019
Typical duration for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2021
CompletedJuly 22, 2022
July 1, 2022
1.3 years
March 23, 2018
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
The effect of cinnamomum cassia on IGF1 levels.
Changes in the levels of IGF1
90 days
The effect of cinnamomum cassia potentiates the insulin response of IGF1 on metabolic control in patients with DM2 without glycemic control treated with metformin.
Changes in the levels of the fasting glucose decrease and glycated hemoglobin
90 days
The effect of cinnamomum cassia on metabolic control in patients with DM2 without glycemic control treated with metformin
Changes in the levels of total cholesterol
90 days
The effect of cinnamomum cassia on metabolic control
Changes in the levels of tryglicerides
90 days
The effect of cinnamomum cassia on blood pressure
Changes in the levels of systolic and diastolic blood pressure
90 days
The effect of cinnamomum cassia on body weight
Changes in the body weight
90 days
Secondary Outcomes (4)
The effect of cinnamomum cassia potentiates the IGF1 insulin response on insulin sensitivity.
90 days
The effect of cinnamomum cassia potentiates the IGF1 insulin response on BMI.
90 days
The effect of cinnamomum cassia potentiates the IGF1 insulin response on waist circumference.
90 days
The effect of cinnamomum cassia potentiates the IGF1 insulin response on body fat%.
90 days
Study Arms (2)
Cinnamomum Cassia
ACTIVE COMPARATORA 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.
Placebo
PLACEBO COMPARATORA 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.
Interventions
The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and the main effect sought is on IGF1 levels, in addition to metabolic control.
The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and comparison with placebo. The main effect sought is on IGF1 levels, in addition to metabolic control.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, 44380, Mexico
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BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra O Hernández González, Doctorado
Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Random assignment of groups and blinding: All participants will be submitted to the selection of a sealed envelope which will have a numerical code previously defined by a third party for each intervention group. The total number of envelopes required to complete the minimum number of participants (28) will be divided according to sex in two boxes, there will be 14 envelopes for men and 14 envelopes for women, with numerical codes that identify the bottle of intervention treatment that should receive the participant during the intervention period. They will be divided into 7 blinded codes for cinnamomum cassia group and 7 for placebo to complete the size of each subsample. Chance guarantees blinding, neither the participant nor the researcher will know the type of treatment. The database for the blinded statistical analysis will be completed. The blind man will be removed once the statistical analysis has been completed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Research Associate C, Unit in Clinical Epidemiology, Specialities Hospital, Medical Unit of High Specialty; West National Medical Center, Mexican Institute of Social Security.
Study Record Dates
First Submitted
March 23, 2018
First Posted
August 1, 2018
Study Start
August 1, 2019
Primary Completion
November 24, 2020
Study Completion
August 18, 2021
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Starting 6 months after publication.
- Access Criteria
- The data can be shared through a request addressed to the principal investigator Dr. Sandra Ofelia Hernández González, basing the reason for what they are requested.
All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)