Type 2 Diabetes MellitusPhase 4NCT00265746
Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes
A Phase 4 study testing Metformin and Lifestyle intervention - diet, physical activity in people with Type 2 Diabetes Mellitus, run by Medical University of Lodz.
Trial summary
Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin and Lifestyle intervention - diet, physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to 1 Jan 2007
- Phase
- Phase 4
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GDM - experienced during pregnancy (diagnosis of GDM according to WHO-criteria)
- Breast-feeding of the newborn finished (lactation finished)
- Actual BMI >= 25 kg/ m2
- Written consent for participation in the study
- A hitherto prevailing good cooperation with the patient
Who cannot join
- Cholestasis during the past pregnancy
- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage,jaundice of unknown etiology)
- Serum ASPAT and/or ALAT level exceeding more than twice normal laboratory values
- Pregnancy planned during the coming two years
- Presence of contradictions for metformin administration according to demands of the Drug Admission Committee in Poland
About this study
Official title: Program for the Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes. Evaluation of the Efficacy of the Life-style Modification and the Life-style Modification in Conjunction With Metformin, in the Prevention of Diabetes Mellitus Development in a Population of Women Who Had Expired a Gestational Diabetes - a Multicenter, Randomized, Double Blind Study.
Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.
The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.
Read the detailed description
Gestational diabetes mellitus (GDM) is one of the most frequent metabolic disorders occurring during pregnancy that complicates both, the course of pregnancy and the delivery and is also responsible for many fetal complications. Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.
Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, a modification of the life style and pharmacotherapy. The use of metformin in patients with a impaired glucose tolerance, resulted in a ca. 30% reduction of the diabetes incidence rate.
The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Lifestyle intervention - diet, physical activity
- Keywords
- metformin, gestational diabetes, lifestyle
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Lifestyle intervention - diet, physical activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes mellitus.
Secondary outcomes (1)
Incidence of IGT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startNov 2005 (estimated)
- Primary completion1 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Katarzyna Cypryk, MD, PhD, Habilitation, Principal investigator, Medical University in Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265746
- Sponsor's protocol ID
- KBN Nr 2 P05001 28
- Status last verified
- Mar 2019
- First submitted
- 14 Dec 2005
- Last updated
- 18 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for the Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes. Evaluation of the Efficacy of the Life-style Modification and the Life-style Modification in Conjunction With Metformin, in the Prevention of Diabetes Mellitus Development in a Population of Women Who Had Expired a Gestational Diabetes - a Multicenter, Randomized, Double Blind Study.
- ClinicalTrials.gov ID
- NCT00265746
- Acronym / sponsor ID
- KBN Nr 2 P05001 28
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- metformin, gestational diabetes, lifestyle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Nov 2005 (estimated)
- Primary completion
- 1 Jan 2007 (actual)
- First posted
- 15 Dec 2005 (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.
Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.
The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.
Detailed description
Gestational diabetes mellitus (GDM) is one of the most frequent metabolic disorders occurring during pregnancy that complicates both, the course of pregnancy and the delivery and is also responsible for many fetal complications. Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.
Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, a modification of the life style and pharmacotherapy. The use of metformin in patients with a impaired glucose tolerance, resulted in a ca. 30% reduction of the diabetes incidence rate.
The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- GDM - experienced during pregnancy (diagnosis of GDM according to WHO-criteria)
- Breast-feeding of the newborn finished (lactation finished)
- Actual BMI >= 25 kg/ m2
- Written consent for participation in the study
- A hitherto prevailing good cooperation with the patient
Key exclusion criteria (5 listed)
- Cholestasis during the past pregnancy
- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage,jaundice of unknown etiology)
- Serum ASPAT and/or ALAT level exceeding more than twice normal laboratory values
- Pregnancy planned during the coming two years
- Presence of contradictions for metformin administration according to demands of the Drug Admission Committee in Poland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | – |
| Lifestyle intervention - diet, physical activity | Behavioural | – |
Primary outcome
Incidence of type 2 diabetes mellitus.
1 secondary outcome
Incidence of IGT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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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.
Katarzyna Cypryk, MD, PhD, Habilitation principal investigator
Medical University in Lodz
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Lifestyle intervention - diet, physical activity in people with Type 2 Diabetes Mellitus, run by Medical University of Lodz.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 2 diabetes mellitus.. 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 18 Mar 2019.