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

NCT ID: NCT04148183

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2009-01-01

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metformin Group

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

Group Type: EXPERIMENTAL

Metformin group

Intervention Type: DRUG

We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks

Rosiglitazone Group

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

Group Type: EXPERIMENTAL

Rosiglitazone group

Intervention Type: DRUG

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

Placebo Group

Placebo treatment was administered for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

We add Placebo, treatment was administered for 8 weeks

Interventions

Metformin group

We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks

Intervention Type: DRUG

Rosiglitazone group

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

Intervention Type: DRUG

Placebo oral tablet

We add Placebo, treatment was administered for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Metformina; Rosiglitazona; Control Group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

J JESUS VENEGAS, MD

OTHER

Sponsor Role: lead

Responsible Party

J JESUS VENEGAS, MD

Master Degree, Nephrologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carlos Tene, DS

Role: STUDY_DIRECTOR

Universidad de Colima

References

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.

Reference Type: BACKGROUND

PMID: 15262452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15000437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14578261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11553189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17229249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23445141 (View on PubMed)

Other Identifiers

Ucol-1

Identifier Type: -

Identifier Source: org_study_id