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

NCT04148183 | Completed Phase 2

• 1 other identifier: Ucol-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• INSULIN RESISTANCE

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

  8 weeks

Secondary Outcomes (1)

• oral glucose tolerance test (OGTT),

  8 weeks

Study Arms (3)

Metformin Group

EXPERIMENTAL

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

Drug: Metformin group

Rosiglitazone Group

EXPERIMENTAL

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

Drug: Rosiglitazone group

Placebo Group

PLACEBO COMPARATOR

Placebo treatment was administered for 8 weeks

Drug: Placebo oral tablet

Interventions

Metformin group DRUG

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

Also known as: Metformina

Metformin Group

Rosiglitazone group DRUG

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

Also known as: Rosiglitazona

Rosiglitazone Group

Placebo oral tablet DRUG

We add Placebo, treatment was administered for 8 weeks

Also known as: Control Group

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• J JESUS VENEGAS, MD: lead
• Instituto Mexicano del Seguro Social: collaborator
• National Council of Science and Technology, Mexico: collaborator

Related Publications (6)

• 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.

  PMID: 15262452 BACKGROUND

• 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.

  PMID: 15000437 BACKGROUND

• 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.

  PMID: 14578261 BACKGROUND

• 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.

  PMID: 11553189 BACKGROUND

• 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.

  PMID: 17229249 BACKGROUND

• 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.

  PMID: 23445141 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin; Rosiglitazone; Control Groups

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carlos Tene, DS

  Universidad de Colima

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Degree, Nephrologist

Model Details: 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

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 1, 2019
• Study Start: January 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2009
• Last Updated: November 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share