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Oral Administration of Cinnamomum Cassia as an Enhancer of the Insulin Response of IGF1 and Metabolic Control in Patients With DM2 Without Glycemic Control Treated With Metformin Diary. (CICAFAC1)

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ClinicalTrials.gov Identifier: NCT03610412
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sandra Ofelia Hernández González, Coordinación de Investigación en Salud, Mexico

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Cinnamomum Cassia Other: Placebo (calcined magnesia) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Cinnamomum Cassia
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
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.

Placebo Comparator: 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 placebo (calcined magnesia) orally every 8 hours, for 90 days.
Other: Placebo (calcined magnesia)
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.




Primary Outcome Measures :
  1. The effect of cinnamomum cassia on IGF1 levels. [ Time Frame: 90 days ]
    Changes in the levels of IGF1

  2. The effect of cinnamomum cassia potentiates the insulin response of IGF1 on metabolic control in patients with DM2 without glycemic control treated with metformin. [ Time Frame: 90 days ]
    Changes in the levels of the fasting glucose decrease and glycated hemoglobin

  3. The effect of cinnamomum cassia on metabolic control in patients with DM2 without glycemic control treated with metformin [ Time Frame: 90 days ]
    Changes in the levels of total cholesterol

  4. The effect of cinnamomum cassia on metabolic control [ Time Frame: 90 days ]
    Changes in the levels of tryglicerides

  5. The effect of cinnamomum cassia on blood pressure [ Time Frame: 90 days ]
    Changes in the levels of systolic and diastolic blood pressure

  6. The effect of cinnamomum cassia on body weight [ Time Frame: 90 days ]
    Changes in the body weight


Secondary Outcome Measures :
  1. The effect of cinnamomum cassia potentiates the IGF1 insulin response on insulin sensitivity. [ Time Frame: 90 days ]
    Changes in insulin sensitivity.

  2. The effect of cinnamomum cassia potentiates the IGF1 insulin response on BMI. [ Time Frame: 90 days ]
    Changes in body mass index..

  3. The effect of cinnamomum cassia potentiates the IGF1 insulin response on waist circumference. [ Time Frame: 90 days ]
    Changes in waist circumference.

  4. The effect of cinnamomum cassia potentiates the IGF1 insulin response on body fat%. [ Time Frame: 90 days ]
    Changes in body fat percentage.



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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The sample size will be 28 patients, 14 men and 14 women.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610412


Contacts
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Contact: Sandra O Hernández González, Doctorado 523336170060 ext 31494 dra_sandy2003@yahoo.com.mx
Contact: María C Espinel Bermúdez, Doctorado 523336170060 ext 31494 mclaudia_espinel@yahoo.com.mx

Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico

Additional Information:
Publications:
American Diabetes Association. Standards of medical care in Diabetes - 2017 Diabetes Care 2017; 40 (Sup1)
Organización Mundial de la Salud. Informe mundial sobre la diabetes. Ginebra, 2016
Instituto Nacional de Salud Pública. Encuesta Nacional de Salud y Nutrición de Medio Camino 2016 Informe Final de Resultados. 2016.
Asociación Latinoamericana de Diabetes. Consenso de Prediabetes. Documento de Posición de la Asociación Latinoamericana de Diabetes (ALAD) 2016.
National Institute for Health and Care Excellence. Preventing type 2 diabetes: risk identification and interventions for individuals at high risk. Public health guideline [PH38] 2012.
Bautista Rodríguez LM, Zambrano Plata GE. La calidad de vida percibida en pacientes diabéticos tipo 2. Investigación en Enfermería: Imagen y Desarrollo. 2015;17(1):131-148.
Guía de Práctica Clínica. Diagnóstico y tratamiento de la retinopatía diabética, 2015. Guía de Referencia Rápida. Catálogo Maestro de Guías de Práctica Clínica: Actualización 2015, IMSS-171-09
Pedraza L. Diabetic neuropathies: classification and diagnosis. Rev. Med. Clin. Condes 2009; 20(5) 681-686.
Julio RA. Galleguillos I. Diabetes and peripheral vascular disease. Rev. Med. Clin. Condes 2009; 20(5) 687-697.
Arauza A, Ruíz-Franco A. Enfermedad vascular cerebral. Rev Fac Med UNAM 2012; 55 (3): 11-21.
Cervantes-Villagrana RD, Presno-Bernal JM. Fisiopatología de la diabetes y los mecanismos de muerte de las células β pancreáticas. Rev Endocrinol Nutr 2013; 21(3): 98-106.
Gunawardane K, Krarup Hansen T, Sandahl Christiansen J, Lunde Jorgensen JO Normal physiology of growth hormone in adults. 2015; South Dartmouth, MA: Endotext.
Goodman y Gilman. Las bases farmacológicas de la terapéutica. 12va. ed. México: McGraw-Hill Interamericana; 2012.
Von Bernhardi M R. Mecanismos de muerte celular en las enfermedades neurodegenerativas: ¿apoptosis o necrosis? Rev Chil Neuro-Psiquiat 2004;42(4):281-92.
Sánchez-Migallón P. Control metabólico en pacientes diabéticos tipo 2: grado de control y nivel de conocimientos (Estudio Azuer) Rev Clin Med Fam 2011; 4(1): 32-4132.
Norma Oficial Mexicana NOM-015-SSA2-1994, Para la prevención, tratamiento y control de la diabetes.
Panickar K, Cao H, Qin B, Anderson RA. Molecular Targets and Health Benefits of Cinnamon. In: Aggarwal BB, Kunnumakkara AB, editors. Molecular Targets and Therapeutic Uses of Spices. Modern Uses for Ancient Medicine. USA:World Scientific; 2009. p. 87-115.
Ravindran PN, Nirmal Babu K, Shylaja M. Cinnamon and Cassia. The genus Cinnamomum. 2004 CRC Press LLC. Boca Raton Florida, USA.
Meena Vangalapati, Sree Satya N, Surya Prakash DV, Sumanjali Avanigadda. A Review on Pharmacological Activities and Clinical effects of Cinnamon Species. RJPBCS 2012; 3(1) 653-663.
Nandam Sree Satya, Surya Prakash D.V., Vangalapati Meena. Purification of Cinnamaldehyde from Cinnamon Species by Column Chromatography. Res J Biological Sci 2012: 1(7): 49-51.
Jiaju Zhou, Guirong Xie, Xinjian Yan. Encyclopedia of Traditional Chinese Medicines - Molecular Structures, Pharmacological Activities, Natural Sources and Applications: Vol. 4: Isolated Compounds N-S. Editorial Springer-Verlang Berlin Heidelberg 2011. p. 535.
Warrier PK, Nambiar VPK, Ramankutty C. Indian Medicinal Plants: A Compendium of 500 Species. Orient Longman, 1994.
Fugh-Berman A. The 5-minute Herb and Dietary Supplement Consult. Lyppincott Williams & Wilkins 2003. p.86-87.
Jeyasselan L. Rao PSS. Methods of determining samples size in clinical trials. Indian Pediatrics 1989; 26: 115-121. Salud Pública de Mex 2007; 49 (2): 94-102.
Compendio de Leyes y Reglamentos. Agenda de Salud 2002. Tercera edición. México: Ediciones fiscals ISEF, 2002
Surós A, Surós J. Semiología médica y técnica exploratoria. Octava edición. Barcelona: MASSON, 2001

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Responsible Party: Sandra Ofelia Hernández González, Medical Research Associate C, Unit in Clinical Epidemiology, Specialities Hospital, Medical Unit of High Specialty; West National Medical Center, Mexican Institute of Social Security., Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03610412     History of Changes
Other Study ID Numbers: R-2018-1301-031
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Ofelia Hernández González, Coordinación de Investigación en Salud, Mexico:
Diabetes Mellitus Type 2
IGF1
Cinnamomum cassia
Metabolic control
Metformin

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Magnesium Oxide
Hypoglycemic Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents