NCT03610412

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2019

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

March 23, 2018

Last Update Submit

July 20, 2022

Conditions

Keywords

Diabetes Mellitus Type 2IGF1Cinnamomum cassiaMetabolic controlMetformin

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 COMPARATOR

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.

Other: Cinnamomum Cassia

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo (calcined magnesia)

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.

Cinnamomum Cassia

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.

Placebo

Eligibility Criteria

Age40 Years - 59 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe sample size will be 28 patients, 14 men and 14 women.
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sandra O Hernández González, Doctorado

    Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02

    PRINCIPAL INVESTIGATOR

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
Model Details: Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group. Process: Visit 1 / Day -7: Period of scrutiny, study information, consent signature, clinical history, anthropometry, baseline laboratory tests. Visit 2 / Day 0: Start the intervention period, simple random assignment for study groups, delivery of medication, general recommendations of diet and exercise. Visit 3 / Day 30 - Visit 4 / Day 60: Adherence to treatment, taking laboratory tests, evaluation of adverse events, general recommendations of diet and exercise, general recommendations of diet and exercise will be evaluated. Final Visit / Day 90 ± 7: Anthropometric measurements will be taken, laboratory tests will be taken, treatment adherence and adverse events will be evaluated, end of the intervention period.
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

All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)

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.

Locations