Impaired Glucose ToleranceTIPNCT00625781
Treatment of Impaired Glucose Tolerance in Pregnancy
A study testing Insulin aspart and Insulin human (isophane) in people with Impaired Glucose Tolerance and Fetal Macrosomia, run by Region Örebro County at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance, Fetal Macrosomia
- What is being tested?
- Insulin aspart and Insulin human (isophane)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2008to Dec 2013
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with 75g OGTT result : fasting capillary plasma <=7.0 mmol/l and/or 2 h value >= 12.2 mmol/l
Who cannot join
- Multiple pregnancy
- Pregestational Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.
- Conditions
- Impaired Glucose Tolerance, Fetal Macrosomia
- Being tested
- Insulin aspart and Insulin human (isophane)
- Keywords
- Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
- Medical subject headings
- Glucose Intolerance, Fetal Macrosomia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin aspart and Insulin human (isophane)Drug
Also called NovoRapid FlexPen, A10AB05, Insulatard FlexPen, A10AC01
Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.
| Study group | Role | What they receive |
|---|---|---|
| B2 | Experimental | IGT randomized to treatment Receives: Drug: Insulin aspart and Insulin human (isophane) |
| B1 | No intervention | IGT randomized to "no treatment" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal morbidity and intrauterine growth
Measured: 1 year post partum
Secondary outcomes (1)
Children´s future health
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Principal investigator, Helena Fadl, Region Örebro County
- Investigators
- Ulf Hanson, Consultant, Study chair, Uppsala Academic Hospital , SwedenIngrid Östlund, MD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625781
- Sponsor's protocol ID
- 061018-237
- Other IDs
- TIP protocol Medscinet
- Acronym
- TIP
- Status last verified
- May 2016
- First submitted
- 1 Feb 2008
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
- ClinicalTrials.gov ID
- NCT00625781
- Acronym / sponsor ID
- TIP / 061018-237
- Conditions
- Impaired Glucose Tolerance, Fetal Macrosomia
- Keywords
- Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- Feb 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Feb 2008 (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 purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B2 | Experimental | Drug: Insulin aspart and Insulin human (isophane)IGT randomized to treatment |
| B1 | No intervention | –IGT randomized to "no treatment" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with 75g OGTT result : fasting capillary plasma <=7.0 mmol/l and/or 2 h value >= 12.2 mmol/l
Key exclusion criteria (2 listed)
- Multiple pregnancy
- Pregestational Diabetes
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 |
|---|---|---|
| Insulin aspart and Insulin human (isophane)Also: NovoRapid FlexPen, A10AB05, Insulatard FlexPen, A10AC01Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol. | Drug | B2 |
Primary outcome
Perinatal morbidity and intrauterine growth
Time frame: 1 year post partum
1 secondary outcome
Children´s future health
Time frame: 5 years
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 11 May 2016.
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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.
Ulf Hanson, Consultant study chair
Uppsala Academic Hospital , Sweden
Ingrid Östlund, MD principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin aspart and Insulin human (isophane) in people with Impaired Glucose Tolerance and Fetal Macrosomia, run by Region Örebro County at 1 site in Sweden.
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 1 inclusion and 2 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 11 May 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 Sweden. 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?
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?
Perinatal morbidity and intrauterine growth (time frame: 1 year post partum). 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 11 May 2016.