Pregestational Obesity (BMI > 27kg/m2)Phase 4NCT01675310
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
A Phase 4 study testing medical nutrition therapy + metformin and Medical nutrition therapy in people with Pregestational Obesity (BMI > 27kg/m2) and History of Polycystic Ovary Syndrome, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial summary
Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregestational Obesity (BMI > 27kg/m2), History of Polycystic Ovary Syndrome
- What is being tested?
- medical nutrition therapy + metformin and Medical nutrition therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Mar 2015
- 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
- Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
- Body mass index > 27 kg/m2
- Maternal age >25
- History of infertility with polycystic ovary syndrome
- History of macrosomic newborn (Weight >4000g)
- History of diabetes mellitus in first or second degree.
- History of gestational diabetes in previous pregnancy
Who cannot join
- Any form of pregestational diabetes
- Fasting glucose > 126 mg/dL at first prenatal visit.
- seric creatinine > 1.5 mg/dL
- Hyperthyroidism
- Heart disease
- Hepatic disease
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- Renal diseases
- Epilepsy
- Lupus
- Chronic hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.
There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.
Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.
Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.
- Being tested
- medical nutrition therapy + metformin, Medical nutrition therapy
- Keywords
- obesity, polycystic ovary syndrome, gestational diabetes
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical nutrition therapy + metforminDrug
Medical nutrition therapyBehavioural
medical nutrition therapy
| Study group | Role | What they receive |
|---|---|---|
| medical nutrition therapy + metformin | Experimental | medical nutrition therapy plus trans-gestational metformin (850mg 2 times day) Receives: Drug: medical nutrition therapy + metformin |
| medical nutrition therapy | Active comparator | medical nutrition therapy without trans-gestational metformin Receives: Behavioral: Medical nutrition therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes mellitus
oral glucose tolerance test
Measured: 27-28 weeks of gestation
Secondary outcomes (1)
insulin resistance
measure of insulin resistance by HOMA-IR, sample of umbilical cord
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregestational Obesity (BMI > 27kg/m2)Studies 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Enrique Reyes-Muñoz, PhD, Principal investigator, National Institute of Perinatology, Mexico City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675310
- Sponsor's protocol ID
- Conacyt 151819
- Other IDs
- INPer (Mexico)
- Status last verified
- Mar 2015
- First submitted
- 27 Aug 2012
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.
PubMed 35010938
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
- ClinicalTrials.gov ID
- NCT01675310
- Acronym / sponsor ID
- Conacyt 151819
- Keywords
- obesity, polycystic ovary syndrome, gestational diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Aug 2012 (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 mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.
There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.
Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.
Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical nutrition therapy + metformin | Experimental | Drug: medical nutrition therapy + metforminmedical nutrition therapy plus trans-gestational metformin (850mg 2 times day) |
| medical nutrition therapy | Active comparator | Behavioral: Medical nutrition therapymedical nutrition therapy without trans-gestational metformin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
Key exclusion criteria (10 listed)
- Any form of pregestational diabetes
- Fasting glucose > 126 mg/dL at first prenatal visit.
- seric creatinine > 1.5 mg/dL
- Hyperthyroidism
- Heart disease
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 |
|---|---|---|
| medical nutrition therapy + metformin | Drug | medical nutrition therapy + metformin |
| Medical nutrition therapymedical nutrition therapy | Behavioural | medical nutrition therapy |
Primary outcome
Gestational diabetes mellitus
Time frame: 27-28 weeks of gestation
oral glucose tolerance test
1 secondary outcome
insulin resistance
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 35010938Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.
- Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women.Link provided by the sponsor.
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.
Enrique Reyes-Muñoz, PhD principal investigator
National Institute of Perinatology, Mexico City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing medical nutrition therapy + metformin and Medical nutrition therapy in people with Pregestational Obesity (BMI > 27kg/m2) and History of Polycystic Ovary Syndrome, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 25 Mar 2015. 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 Mexico. 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gestational diabetes mellitus (time frame: 27-28 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675310, which also lists 1 linked publication.
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 25 Mar 2015.