Insulin Resistance Clinical Trial
Official title:
Developmental ORIgins of Healthy and Unhealthy AgeiNg: the Role of Maternal Obesity
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:
- 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).
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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