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
About this trial
This is an interventional treatment trial for Insulin Resistance
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.
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
NCT ID
NCT04148183
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
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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