Type 2 DiabetesNCT02048839
Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
An observational study of Type 2 Diabetes and Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
SUBJECTS: All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires OVERALL OBJECTIVES: 1. Read more about this study
- Who is it for?
- Ages 3 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Metabolic Syndrome
- How many people
- 680 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2014to Aug 2017
- 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 3 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Women who participated the Radiel intervention study, and were originally randomly assigned to either active lifestyle intervention group or control group. They were all high risk women with BMI >30 or prior gestational GDM. To this follow up-study we invite also the children born during the intervention.
Who may be able to join
- all study subjects form Radiel intervention study, who delivered a baby
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
SUBJECTS:
All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires
Read more
OVERALL OBJECTIVES:
- To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
- To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
- To study the association between gut microbiota and markers of offspring health
- To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
- To study the cost effectiveness of the intervention.
METHODS:
Maternal measurements
- Height, weight, waist and hip circumference
- Blood pressure, pulse
- Body fat percentage
- Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
- Fecal and hair samples
- Diurnal salivary cortisol assessment
- Background questionnaire: socioeconomic and health-related background
- Health-related quality of life (15-D).
- 3-day food diary and exercise diary
- ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
- Psychological questionnaires
- Pulse wave velocity (PWV) will be assessed
- Advanced glycation endproducts - a marker of cardiovascular health will be assessed
- Dental and oral health
- Bone health
- VHRU of arterial structure
Paternal measurements
- Background questionnaire (incl. height, weight, age)
- DNA-sample (buccal)
- 3-day food diary
- Psychological questionnaires
- Physical activity questionnaire (12 months)
Measurements of children
- Body weight, height, blood pressure, pulse
- Body fat percentage
- Psychological questionnaires
- Food and physical activities diaries
- ActiGraph, assessment of physical activity and sleep for 7 days
- Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
- Fecal, urine and hair samples
- A copy of child welfare center card (e.g. data on growth, immunizations, health)
- Endothelial function and pulse wave velocity (PWV)
- Bone health with peripheral CT
- Heart structure and function
- VHRU of arterial structure
TIMETABLE
Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.
- Conditions
- Type 2 Diabetes, Obesity, Metabolic Syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiel Intervention group and their children | Participated the Radiel- intervention study (2008-2011) in the Intervention group: Lifestyle counselling during and after pregnancy (up to 1 year post partum) | |
| Radiel Control Group with their children | Control group in the Radiel- intervention study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 Diabetes
Measured: 3-5 years post partum
Secondary outcomes (1)
Metabolic syndrome and cardiovascular morbidity
Measured: 3-5 years post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saila Koivusalo, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048839
- Sponsor's protocol ID
- Radiel 5Y
- Status last verified
- Apr 2019
- First submitted
- 27 Jan 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
- ClinicalTrials.gov ID
- NCT02048839
- Acronym / sponsor ID
- Radiel 5Y
- Conditions
- Type 2 Diabetes, Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Jan 2014 (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.
SUBJECTS:
All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires
OVERALL OBJECTIVES:
- To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
- To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
- To study the association between gut microbiota and markers of offspring health
- To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
- To study the cost effectiveness of the intervention.
METHODS:
Maternal measurements
- Height, weight, waist and hip circumference
- Blood pressure, pulse
- Body fat percentage
- Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
- Fecal and hair samples
- Diurnal salivary cortisol assessment
- Background questionnaire: socioeconomic and health-related background
- Health-related quality of life (15-D).
- 3-day food diary and exercise diary
- ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
- Psychological questionnaires
- Pulse wave velocity (PWV) will be assessed
- Advanced glycation endproducts - a marker of cardiovascular health will be assessed
- Dental and oral health
- Bone health
- VHRU of arterial structure
Paternal measurements
- Background questionnaire (incl. height, weight, age)
- DNA-sample (buccal)
- 3-day food diary
- Psychological questionnaires
- Physical activity questionnaire (12 months)
Measurements of children
- Body weight, height, blood pressure, pulse
- Body fat percentage
- Psychological questionnaires
- Food and physical activities diaries
- ActiGraph, assessment of physical activity and sleep for 7 days
- Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
- Fecal, urine and hair samples
- A copy of child welfare center card (e.g. data on growth, immunizations, health)
- Endothelial function and pulse wave velocity (PWV)
- Bone health with peripheral CT
- Heart structure and function
- VHRU of arterial structure
TIMETABLE
Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiel Intervention group and their children | – | –Participated the Radiel- intervention study (2008-2011) in the Intervention group: Lifestyle counselling during and after pregnancy (up to 1 year post partum) |
| Radiel Control Group with their children | – | –Control group in the Radiel- intervention study. |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women who participated the Radiel intervention study, and were originally randomly assigned to either active lifestyle intervention group or control group. They were all high risk women with BMI >30 or prior gestational GDM. To this follow up-study we invite also the children born during the intervention.
Key inclusion criteria (1 listed)
- all study subjects form Radiel intervention study, who delivered a baby
Key exclusion criteria (1 listed)
- none.
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
Type 2 Diabetes
Time frame: 3-5 years post partum
1 secondary outcome
Metabolic syndrome and cardiovascular morbidity
Time frame: 3-5 years post partum
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 16 Apr 2019.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 Diabetes and Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 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 16 Apr 2019. 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 Finland. 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?
Type 2 Diabetes (time frame: 3-5 years 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 16 Apr 2019.