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Maternal-Fetal RelationsDORIANNCT01931540

Developmental ORIgins of Healthy and Unhealthy AgeiNg: the Role of Maternal Obesity

A study testing Exercise Training in people with Maternal-Fetal Relations and Muscle Weakness, run by Turku University Hospital at 2 sites 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

The prevalence of obesity in the developed world has increased markedly over the last 20 years. Considering the prevalence of obese and overweight adult subjects, and the fact that pregnancy itself induces a state of insulin resistance and inflammation, maternal obesity may be the most common health risk for the… Read more about this study

Who is it for?
Any age, women only
What is being tested?
Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesFinland
Study dates
Jun 2012to Jun 2015
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must be already participating the Helsinki Birth Cohort Study
  • Frailty Groups Inclusion Criteria:
  • (Frailty) with lowest half of adult grip strength (measured 2001-2004)
  • Group OM: (Offspring of Obese mothers) Highest quartile of maternal BMI
  • Group LM: (Offspring of Normal weight/Lean mothers) Lowest two quartiles of maternal BMI
  • Control group Inclusion Criteria:
  • (no Frailty) with highest half of adult grip strength (measured 2001-2004)
  • Offspring of normal weight mothers

Who cannot join

  • Subjects whose mothers were pre-eclamptic during pregnancy
  • Oral corticosteroid or Warfarin therapy
  • Recent myocardial infarction
  • Severe chronic disorder that can prevent to participate the intervention
  • Chronic atrial fibrillation and pacemaker
  • Cancer less than 5 years ago
Show all 11Show fewer
  • Current smoking
  • Diabetes requiring insulin treatment or fasting glucose more than 7 mmol/l
  • Weight more than 170 kg and Waist circumference > 150 cm
  • Inner ear implants
  • Metal objects in body including metallic prostheses, artificial valve prostheses, surgical clips, braces, foreign fragments or tattoo

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • University of Helsinki, Department of General Practice and Primary Health Care

    Helsinki, 00014

  • Turku PET Centre (Turku University Hospital)

    Turku, 20521

Other trials in Finland

About this study

The prevalence of obesity in the developed world has increased markedly over the last 20 years. Considering the prevalence of obese and overweight adult subjects, and the fact that pregnancy itself induces a state of insulin resistance and inflammation, maternal obesity may be the most common health risk for the developing fetus. It is well established that what we eat has a major impact on our health. However, there is growing evidence to suggest that diet during pregnancy and lactation may be particularly important as not only does it influence the health of the mother, it may have a permanent effect on the health of her children and even her grandchildren. The concept that environmental factors, such as nutrition during early development, influence both our health span and lifespan has been termed the developmental origins of health and disease hypothesis.

The objective of the study are:

Read more
  • to compare subjects with frailty (condition developed with ageing) with controls and characterize the unhealthy aged condition with the measurements described below
  • to examine if signs of frailty can be reversed by lifestyle induced modifications (exercise training programme) of its primary components (IR, sarcopenia, psychological profile) in offspring of overweight/obese (OOM) vs lean mothers (OLM).

The study consists of 37 frail old subjects, age ≥ 65 sub-grouped in 17 OOM, and 20 OLM and 11 non frail controls. These subjects will be studied with positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI) and spectroscopy (MRS) and ultra sounds (US). In addition functional MRI (fMRI) will be performed. Adipose tissue biopsies will be taken.

Subjects will undergo characterization of biohumoral markers, a 75 g oral glucose tolerance test, imaging biomarkers (PET/CT, US, fMRI-MRS), genetic biomarkers (DNA and telomere damage) and inflammatory biomarkers (macrophage infiltration) before and after the 4-month lifestyle intervention period (physical exercise). By PET/CT it will be measured tissue-specific IR in skeletal muscle, adipose tissue, liver, myocardium and targeted brain regions. MRS will be used to measure organ steatosis in the skeletal muscle and liver, MRI will be used to measure fat masses in abdominal areas, and fMRI will be performed to assess activation in brain regions regulating cognition and appetite/energy control. US will be used to assess cardiovascular markers (IMT, strain and function).

Being tested
Exercise Training
Keywords
Obesity, Epigenesis, Genetic, Exercise Therapy
Medical subject headings
Muscle Weakness, Insulin Resistance, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01931540
Study groupRoleWhat they receive
Exercise Training - 17 offspring of OMExperimental4 months exercise training, OM: Obese mothers
Receives: Behavioral: Exercise Training
11 non-frail controls (9 LM)No interventionStudied only at baseline
Exercise Training - 20 offspring of LMExperimental4 months exercise training, LM:Lean/Normal Mothers
Receives: Behavioral: Exercise Training

What is being measured

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

  1. Baseline group comparison and Change from Baseline in Insulin-stimulated whole body and organ-specific glucose uptake at 4 months

    Assessed via 18F-Fluorodeoxyglucose (FDG)-PET/CT+Clamp technique

    Measured: At day 1 and after 4 months of intervention (for the 15 controls only at baseline)

  2. Baseline group comparison and Change from Baseline in Epigenetic characterization of DNA samples (Telomere length, H2A.X phosphorilation, mtDNA deletion, p66) at 4 months

    Telomere length, H2A.X phosphorilation, mtDNA deletion are measurements performed in Pisa, National Research Council p66 presence is measured in Rome, Istituto Superiore di Sanita'

    Measured: At day 1 and after 4 months of intervention (for the 15 controls only at baseline)

Secondary outcomes (2)

  1. Baseline group comparison and Change from Baseline in Fat masses and content via MRI and MRS at 4 months

    Adipose tissue fat masses in different depots (subcutaneous, visceral, pericardial) Liver, skeletal muscle, vertebral fat content

    Measured: At day 1 and after 4 months of intervention (for the 15 controls only at baseline)

  2. Baseline group comparison and Change from Baseline in MRI brain anatomy and fMRI characterization of activation response to food stimuli of different brain regions at 4 months

    MRI anatomy: White matter volume, Cortex thickness, Nerve tracks found with Diffusor Tension Imaging fMRI will be used to identify different brain regions activated by food stimuli while subjects perform three different task: watch the food, think of eating the food, control the urge to eat the food.

    Measured: At day 1 and after 4 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2014
  4. Study completionJun 2015

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931540
Sponsor's protocol ID
T55/2012b
Other IDs
EC-FP7-278603
Acronym
DORIAN
Status last verified
Mar 2016
First submitted
22 Apr 2013
Last updated
22 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Berry A, Bucci M, Raggi C, Eriksson JG, Guzzardi MA, Nuutila P, Huovinen V, Iozzo P, Cirulli F. Dynamic changes in p66Shc mRNA expression in peripheral blood mononuclear cells following resistance training intervention in old frail women born to obese mothers: a pilot study. Aging Clin Exp Res. 2018 Jul;30(7):871-876. doi: 10.1007/s40520-017-0834-4. Epub 2017 Sep 26.

    PubMed 28952131

  • Huovinen V, Bucci M, Lipponen H, Kiviranta R, Sandboge S, Raiko J, Koskinen S, Koskensalo K, Eriksson JG, Parkkola R, Iozzo P, Nuutila P. Femoral Bone Marrow Insulin Sensitivity Is Increased by Resistance Training in Elderly Female Offspring of Overweight and Obese Mothers. PLoS One. 2016 Sep 26;11(9):e0163723. doi: 10.1371/journal.pone.0163723. eCollection 2016.

    PubMed 27669153

  • Bucci M, Huovinen V, Guzzardi MA, Koskinen S, Raiko JR, Lipponen H, Ahsan S, Badeau RM, Honka MJ, Koffert J, Savisto N, Salonen MK, Andersson J, Kullberg J, Sandboge S, Iozzo P, Eriksson JG, Nuutila P. Resistance training improves skeletal muscle insulin sensitivity in elderly offspring of overweight and obese mothers. Diabetologia. 2016 Jan;59(1):77-86. doi: 10.1007/s00125-015-3780-8.

    PubMed 26486356

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training in people with Maternal-Fetal Relations and Muscle Weakness, run by Turku University Hospital at 2 sites 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 8 inclusion and 11 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Baseline group comparison and Change from Baseline in Insulin-stimulated whole body and organ-specific glucose uptake at 4 months (time frame: At day 1 and after 4 months of intervention (for the 15 controls only at baseline)). The study lists 2 primary outcomes in all. 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 NCT01931540, which also lists 3 linked publications.

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 22 Mar 2016.

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