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Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin group
Rosiglitazone group
Placebo oral tablet
Sponsored by
J JESUS VENEGAS, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years old.
  • Metabolic Syndrome criteria of World Health Organization .

Exclusion Criteria:

  • Diabetes Mellitus
  • Allergic to Metformin,
  • Allergic to rosiglitazone.
  • Hepatic disease.
  • Hearth disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Metformin Group

    Rosiglitazone Group

    Placebo Group

    Arm Description

    Metformin (850 mg/day) treatment was administered for 8 weeks

    Rosiglitazone (4 mg/day), treatment was administered for 8 weeks

    Placebo treatment was administered for 8 weeks

    Outcomes

    Primary Outcome Measures

    INSULIN RESISTANCE
    INSULIN RESISTANCE index (Homeostatic Model) is method that need insulin concentration and glucose in blood to calculate index.

    Secondary Outcome Measures

    oral glucose tolerance test (OGTT),
    oral glucose tolerance test was done take a sample of blood before a period without feed of 8 hours, we took a blood glucose sample then we gave a 75g of glucose and after we took blood glucose at the hour and 2 hours of OGTT test

    Full Information

    First Posted
    October 29, 2019
    Last Updated
    October 31, 2019
    Sponsor
    J JESUS VENEGAS, MD
    Collaborators
    Instituto Mexicano del Seguro Social, National Council of Science and Technology, Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04148183
    Brief Title
    Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.
    Official Title
    Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2004 (Actual)
    Primary Completion Date
    January 1, 2005 (Actual)
    Study Completion Date
    January 1, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    J JESUS VENEGAS, MD
    Collaborators
    Instituto Mexicano del Seguro Social, National Council of Science and Technology, Mexico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. A randomized blinded clinical trial did in patients with metabolic syndrome (n=30), without diabetes. Prior to detailed information and signature of informed consent by patients were done three treatment groups by randomized technique; a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin.
    Detailed Description
    Metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins, and obesity. Metformin and rosiglitazone are two insulinosensensitizers used in the treatment of diabetes. Now there is controversy over the use of insulinossensitizers in non-diabetic patients with metabolic syndrome. To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. Randomized blinded clinical trial in patients with metabolic syndrome without diabetes was done, sample size (n=30). Prior to detailed information and signature of informed consent by patients was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin. Statistic no parametric (Kruskal Wallis, Wilcoxon, U Mann Whitney) to compare characteristics inter o intra groups was done. Exact Fisher test was used for qualitative variable, and consider significance with p<0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prior to detailed information and signature of informed consent by patients, it was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin Group
    Arm Type
    Experimental
    Arm Description
    Metformin (850 mg/day) treatment was administered for 8 weeks
    Arm Title
    Rosiglitazone Group
    Arm Type
    Experimental
    Arm Description
    Rosiglitazone (4 mg/day), treatment was administered for 8 weeks
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo treatment was administered for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin group
    Other Intervention Name(s)
    Metformina
    Intervention Description
    We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Rosiglitazone group
    Other Intervention Name(s)
    Rosiglitazona
    Intervention Description
    we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral tablet
    Other Intervention Name(s)
    Control Group
    Intervention Description
    We add Placebo, treatment was administered for 8 weeks
    Primary Outcome Measure Information:
    Title
    INSULIN RESISTANCE
    Description
    INSULIN RESISTANCE index (Homeostatic Model) is method that need insulin concentration and glucose in blood to calculate index.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    oral glucose tolerance test (OGTT),
    Description
    oral glucose tolerance test was done take a sample of blood before a period without feed of 8 hours, we took a blood glucose sample then we gave a 75g of glucose and after we took blood glucose at the hour and 2 hours of OGTT test
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: > 18 years old. Metabolic Syndrome criteria of World Health Organization . Exclusion Criteria: Diabetes Mellitus Allergic to Metformin, Allergic to rosiglitazone. Hepatic disease. Hearth disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Tene, DS
    Organizational Affiliation
    Universidad de Colima
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15262452
    Citation
    Seufert J, Lubben G, Dietrich K, Bates PC. A comparison of the effects of thiazolidinediones and metformin on metabolic control in patients with type 2 diabetes mellitus. Clin Ther. 2004 Jun;26(6):805-18. doi: 10.1016/s0149-2918(04)90125-7.
    Results Reference
    background
    PubMed Identifier
    15000437
    Citation
    Gulias-Herrero A, Aguilar-Salinas CA, Gomez-Perez FJ, Rull JA. The combination metformin/glyburide exerts its hypoglycemic effect mainly by increasing insulin secretion: a controlled, randomized, double-blind, crossover study. Diabetes Nutr Metab. 2003 Oct-Dec;16(5-6):268-76.
    Results Reference
    background
    PubMed Identifier
    14578261
    Citation
    Davidson MB. Is treatment of insulin resistance beneficial independent of glycemia? Diabetes Care. 2003 Nov;26(11):3184-6. doi: 10.2337/diacare.26.11.3184. No abstract available.
    Results Reference
    background
    PubMed Identifier
    11553189
    Citation
    Lehtovirta M, Forsen B, Gullstrom M, Haggblom M, Eriksson JG, Taskinen MR, Groop L. Metabolic effects of metformin in patients with impaired glucose tolerance. Diabet Med. 2001 Jul;18(7):578-83. doi: 10.1046/j.1464-5491.2001.00539.x.
    Results Reference
    background
    PubMed Identifier
    17229249
    Citation
    Derosa G, D'Angelo A, Ragonesi PD, Ciccarelli L, Piccinni MN, Pricolo F, Salvadeo SA, Montagna L, Gravina A, Ferrari I, Paniga S, Cicero AF. Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with metformin. Intern Med J. 2007 Feb;37(2):79-86. doi: 10.1111/j.1445-5994.2007.01238.x.
    Results Reference
    background
    PubMed Identifier
    23445141
    Citation
    Mohiyiddeen L, Watson AJ, Apostolopoulos NV, Berry R, Alexandraki KI, Jude EB. Effects of low-dose metformin and rosiglitazone on biochemical, clinical, metabolic and biophysical outcomes in polycystic ovary syndrome. J Obstet Gynaecol. 2013 Feb;33(2):165-70. doi: 10.3109/01443615.2012.745839.
    Results Reference
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    Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.

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