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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Finland1 site
  • Helsinki University

    Helsinki

Other trials in Finland

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:

  1. 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 .
  2. To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
  3. To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
  4. 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.
  5. To study the association between gut microbiota and markers of offspring health
  6. To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
  7. To study the cost effectiveness of the intervention.

METHODS:

Maternal measurements

  1. Height, weight, waist and hip circumference
  2. Blood pressure, pulse
  3. Body fat percentage
  4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
  5. Fecal and hair samples
  6. Diurnal salivary cortisol assessment
  7. Background questionnaire: socioeconomic and health-related background
  8. Health-related quality of life (15-D).
  9. 3-day food diary and exercise diary
  10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
  11. Psychological questionnaires
  12. Pulse wave velocity (PWV) will be assessed
  13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed
  14. Dental and oral health
  15. Bone health
  16. VHRU of arterial structure

Paternal measurements

  1. Background questionnaire (incl. height, weight, age)
  2. DNA-sample (buccal)
  3. 3-day food diary
  4. Psychological questionnaires
  5. Physical activity questionnaire (12 months)

Measurements of children

  1. Body weight, height, blood pressure, pulse
  2. Body fat percentage
  3. Psychological questionnaires
  4. Food and physical activities diaries
  5. ActiGraph, assessment of physical activity and sleep for 7 days
  6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
  7. Fecal, urine and hair samples
  8. A copy of child welfare center card (e.g. data on growth, immunizations, health)
  9. Endothelial function and pulse wave velocity (PWV)
  10. Bone health with peripheral CT
  11. Heart structure and function
  12. 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.

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 groups in NCT02048839
Study groupRoleWhat they receive
Radiel Intervention group and their childrenParticipated 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 childrenControl group in the Radiel- intervention study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type 2 Diabetes

    Measured: 3-5 years post partum

Secondary outcomes (1)
  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.

  1. First posted29 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

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)
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

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.

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Clinical Trial NCT02048839 | AzTrials