HyperinsulinemiaNCT01409382
Maternal Lifestyle and Neonatal Hypoglycemia
A study testing Daily brisk walking plus a carbohydrate-restricted diet in people with Hyperinsulinemia and Miscarriages, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.
Trial summary
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane (directly or through activation of matrix metalloproteinases) and formation of hemidesmosomes. Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Hyperinsulinemia, Miscarriages, Pregnancy
- What is being tested?
- Daily brisk walking plus a carbohydrate-restricted diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion criteria: recurrent early unexplained miscarriages Exclusion criteria: (i) antiphospholipid antibodies, (ii) second- or third-trimester losses, (iii) multiple pregnancy, (iv) anatomical abnormalities that could increase the risk of early miscarriages, (iv) any condition requiring a priori anticoagulation, (v) protocol violation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Rio de Janeiro, 20221-903
About this study
Official title: Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane (directly or through activation of matrix metalloproteinases) and formation of hemidesmosomes.
A high-carbohydrate intake combined with lack of physical activity provides a strong stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional and diabetes supervenes, or excessive amounts of insulin are produced, providing pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm deliveries and intrauterine growth restriction.
Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of insulin.
Read the detailed description
In an observational study, we sought to determine whether markers of hyperinsulinemia or situations that increase maternal insulin requirements would increase the risk of neonatal hypoglycemia. Mothers were selected if they had grade III obesity, acanthosis nigricans (surrogates of chronic maternal hyperinsulinemia), any invasive bacterial infection or if they had used corticosteroid within seven days before delivery (surrogates of subacute insulin resistance), if they reported to have consumed a high-glycemic index diet within 24 hours before delivery or if they were physically inactive within 24 hours before delivery (conditions that could increase maternal insulin requirements close to delivery).
Based on the finding that that the risk of neonatal hypoglycemia increased fivefold with inactivity (95% CI: 2-11, P <0.001), 11-fold with high-carbohydrate intake (95% CI: 4-24, P <0.001) and 329-fold with both risk factors (95% CI: 32-3362, P <0.001), next we have evaluated how a protocol combining exercises and a balanced diet throughout pregnancy influences maternal and neonatal outcomes. One of the outcomes analyzed was neonatal hypoglycemia.
- Conditions
- Hyperinsulinemia, Miscarriages, Pregnancy, Sedentary Lifestyle, Hypoglycemia
- Being tested
- Daily brisk walking plus a carbohydrate-restricted diet
- Keywords
- neonatal hypoglycemia, pregnancy, physical activity, sedentary lifestyle, high-glycemic index diet, take-home baby, recurrent miscarriages, preterm delivery
- Medical subject headings
- Hyperinsulinism, Abortion, Spontaneous, Sedentary Behavior, Hypoglycemia, Motor Activity, Abortion, Habitual, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily brisk walking plus a carbohydrate-restricted dietBehavioural
Daily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Daily brisk walking plus a carbohydrate-restricted diet Receives: Behavioral: Daily brisk walking plus a carbohydrate-restricted diet |
| Standard follow-up | No intervention | Prenatal care will proceed according to the routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hypoglycemia
Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
Measured: 1, 2 and 4 h after birth.
Secondary outcomes (1)
Refractory Hypoglycemia
Any glucose level ≤ 40/dL at 1, 2 or 4 h:
- Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.
- A new heel stick blood sample will be drawn to assess glucose levels.
- Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.
Measured: One hour after feeding or after intravenous dextrose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperinsulinemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital dos Servidores do Estado do Rio de Janeiro
- Sponsor type
- Other government
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Silvia Hoirisch Clapauch, Hospital dos Servidores do Estado do Rio de Janeiro
- Investigators
- Maria A Sayeg-Porto, MD, PhD, Principal investigator, Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de JaneiroPaulo R Benchimol-Barbosa, MD, DSc, Principal investigator, Universidade Gama Filho; COPPE/UFRJSilvia Hoirisch-Clapauch, MD, Principal investigator, Hospital dos Servidores do Estado, RJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409382
- Sponsor's protocol ID
- 000416-09-08-2010
- Status last verified
- Aug 2016
- First submitted
- 27 May 2011
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT01409382
- Acronym / sponsor ID
- 000416-09-08-2010
- Conditions
- Hyperinsulinemia, Miscarriages, Pregnancy, Sedentary Lifestyle, Hypoglycemia
- Keywords
- neonatal hypoglycemia, pregnancy, physical activity, sedentary lifestyle, high-glycemic index diet, take-home baby, recurrent miscarriages, preterm delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Hospital dos Servidores do Estado do Rio de JaneiroOther government
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 21 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane (directly or through activation of matrix metalloproteinases) and formation of hemidesmosomes.
A high-carbohydrate intake combined with lack of physical activity provides a strong stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional and diabetes supervenes, or excessive amounts of insulin are produced, providing pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm deliveries and intrauterine growth restriction.
Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of insulin.
Detailed description
In an observational study, we sought to determine whether markers of hyperinsulinemia or situations that increase maternal insulin requirements would increase the risk of neonatal hypoglycemia. Mothers were selected if they had grade III obesity, acanthosis nigricans (surrogates of chronic maternal hyperinsulinemia), any invasive bacterial infection or if they had used corticosteroid within seven days before delivery (surrogates of subacute insulin resistance), if they reported to have consumed a high-glycemic index diet within 24 hours before delivery or if they were physically inactive within 24 hours before delivery (conditions that could increase maternal insulin requirements close to delivery).
Based on the finding that that the risk of neonatal hypoglycemia increased fivefold with inactivity (95% CI: 2-11, P <0.001), 11-fold with high-carbohydrate intake (95% CI: 4-24, P <0.001) and 329-fold with both risk factors (95% CI: 32-3362, P <0.001), next we have evaluated how a protocol combining exercises and a balanced diet throughout pregnancy influences maternal and neonatal outcomes. One of the outcomes analyzed was neonatal hypoglycemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Daily brisk walking plus a carbohydrate-restricted dietDaily brisk walking plus a carbohydrate-restricted diet |
| Standard follow-up | No intervention | –Prenatal care will proceed according to the routine. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Daily brisk walking plus a carbohydrate-restricted dietDaily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine. | Behavioural | Lifestyle counseling |
Primary outcome
Neonatal Hypoglycemia
Time frame: 1, 2 and 4 h after birth.
Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
1 secondary outcome
Refractory Hypoglycemia
Time frame: One hour after feeding or after intravenous dextrose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationHoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.
- Individual participant dataSharing planned: Yes
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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.
Maria A Sayeg-Porto, MD, PhD principal investigator
Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro
Paulo R Benchimol-Barbosa, MD, DSc principal investigator
Universidade Gama Filho; COPPE/UFRJ
Silvia Hoirisch-Clapauch, MD principal investigator
Hospital dos Servidores do Estado, RJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily brisk walking plus a carbohydrate-restricted diet in people with Hyperinsulinemia and Miscarriages, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Sep 2016. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neonatal Hypoglycemia (time frame: 1, 2 and 4 h after birth.). 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 NCT01409382, 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 29 Sep 2016.