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Metformin Therapy in Type 1 Diabetes Mellitus.

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ClinicalTrials.gov Identifier: NCT01889706
Recruitment Status : Unknown
Verified June 2013 by Agnieszka Zawada, Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Agnieszka Zawada, Poznan University of Medical Sciences

Brief Summary:

The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus.

The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the Poznan University of Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group I). Metformin is administered at least 6 months at a mean dose of 1000 mg/day.

The investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.


Condition or disease
Loss of Control of Diabetes

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.
Study Start Date : January 2009
Actual Primary Completion Date : March 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Body fat content and anthropometric parameters [ Time Frame: 6 months ]
    assessed by electrical bioimpedance using a Tanita BC-418 MA device,


Secondary Outcome Measures :
  1. Assessment of metabolic control [ Time Frame: 6 months ]
    (HbA1C, lipid profile)

  2. Insulin requirement [ Time Frame: 3 , 6 months ]

Other Outcome Measures:
  1. Assessment of skin AGE [ Time Frame: 6 months ]
    AGE-Reader ( Diagn-Optic)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 Caucasian patients with type 1 diabetes admitted to the Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences in years 2009-2014, treated with intensive insulintherapy.
Criteria

Inclusion Criteria:

  • age > 18 years <60 years,
  • duration of diabetes >3 years,
  • lack of metabolic control- HbA1C>7,5% (despite participation in 5-day WHO education program)
  • treated with intensive insulin therapy

Exclusion Criteria:

  • metabolically decompensate diabetes with acetonuria,
  • suspected lack of compliance,
  • lack of glucose and ketones self-monitoring,
  • hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
  • recurrent diabetic ketoacidosis (more than two episodes in the past year)
  • another serious medical illness,
  • pregnancy or sexually active woman unwilling to take birth control.
  • renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR<45 mL / min
  • liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),
  • history of drug or alcohol abuse or those who used this drug before
  • changes in the way of antihypertensive and antihyperlipemic treatment.

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): NCT01889706


Locations
Poland
Department of Internal Medicine and Diabetology, Raszeja Hospital Recruiting
Poznan, Great Poland, Poland, 60-834
Contact: Agnieszka Zawada, MD       aga.zawada@gmail.com   
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Principal Investigator: Dariusz Naskręt, PhD Poznań University of Medical Sciences

Responsible Party: Agnieszka Zawada, MD, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01889706     History of Changes
Other Study ID Numbers: MTiT1DM
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by Agnieszka Zawada, Poznan University of Medical Sciences:
Type 1 diabetes mellitus,
metformin,
insulin resistance,
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs