Loss of Control of DiabetesNCT01889706
Metformin Therapy in Type 1 Diabetes Mellitus.
An observational study of Loss of Control of Diabetes, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Loss of Control of Diabetes
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2009to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine and Diabetology, Raszeja Hospital
Poznan, Great Poland, 60-834
Agnieszka Zawada, MD, aga.zawada@gmail.com
About this study
Official title: Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.
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.
- Conditions
- Loss of Control of Diabetes
- Keywords
- Type 1 diabetes mellitus,, metformin,, insulin resistance,, obesity
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat content and anthropometric parameters
assessed by electrical bioimpedance using a Tanita BC-418 MA device,
Measured: 6 months
Secondary outcomes (2)
Assessment of metabolic control
(HbA1C, lipid profile)
Measured: 6 months
Insulin requirement
Measured: 3 , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Control of DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Zawada, Poznan University of Medical Sciences
- Investigators
- Dariusz Naskręt, PhD, Principal investigator, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889706
- Sponsor's protocol ID
- MTiT1DM
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01889706
- Acronym / sponsor ID
- MTiT1DM
- Conditions
- Loss of Control of Diabetes
- Keywords
- Type 1 diabetes mellitus,, metformin,, insulin resistance,, obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2014 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body fat content and anthropometric parameters
Time frame: 6 months
assessed by electrical bioimpedance using a Tanita BC-418 MA device,
2 secondary outcomes
Assessment of metabolic control
Time frame: 6 months
Insulin requirement
Time frame: 3 , 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariusz Naskręt, PhD principal investigator
Poznań University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loss of Control of Diabetes, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat content and anthropometric parameters (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.