Clinical trial NCT00268541: Physical Activity, Insulin Resistance and Function of Fat Tissue in the Offspring of Patients With Type 2 Diabetes
Official title: Physical Activity, Insulin Resistance and Adipose Tissue Gene Expression in the Offspring of Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Diseases
Keywords: exercise
physical activity
insulin resistance
adipose tissue
gene expression
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2005-12-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Offspring of patients with type 2 diabetes have increased risk of developing diabetes and are typically more insulin resistant than their peers with no diabetes family history. We have recently demonstrated that, in contrast to their sedentary counterparts, physically active offspring are not insulin resistant. In the proposed controlled clinical study, we will examine the effects of a moderate exercise programme on insulin resistance, and other metabolic risk factors, in sedentary offspring and matched control subjects. We hypothesise that offspring will exhibit an augmented response to exercise, thereby normalising their predisposition to an adverse metabolic profile. We will also investigate expression of adipokines and other genes in adipose tissue to determine whether these contribute to the increased insulin resistance observed in offspring and whether they are influenced by exercise. The results will help to determine the efficacy of exercise in normalising metabolism in offspring and will help elucidate the mechanisms involved.


Eligibility criteria: Inclusion Criteria:

* 2 subject groups - 'control' and 'offspring'
* Offspring - at least 1 parent diagnosed with type 2 diabetes before age 65
* Controls - no history of type 2 diabetes in 1st or 2nd degree relatives
* In generally good health
* Non-smoker
* Fasting glucose \< 7 mmol/l
* Blood pressure \<160/90 mm Hg
* No established CHD (e.g. MI, stroke, CABG, PCTA)

Exclusion Criteria:

* Established CHD (e.g. MI, stroke, CABG, PCTA)
* diabetes
* smoking
* hypertension (BP \> 160/90 mmHg)
* pregnancy

Primary outcomes:
measure: Insulin resistance at 8 weeks
measure: Risk markers for cardiovascular disease/diabetes at 8 weeks
measure: Adipose tissue gene expression at 8 weeks
Secondary outcomes:
measure: Fitness at 8 weeks
measure: Body composition/adiposity at 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Jason MR Gill, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higgins S, Gill JM, Janilionyte R, Caslake MJ, Malkova D. Physical activity, dietary intake and metabolic risk factors in non-diabetic daughters of patients with type II diabetes. Prev Med. 2005 Feb;40(2):145-51. doi: 10.1016/j.ypmed.2004.05.004.
citation: Barwell ND, Malkova D, Moran CN, Cleland SJ, Packard CJ, Zammit VA, Gill JM. Exercise training has greater effects on insulin sensitivity in daughters of patients with type 2 diabetes than in women with no family history of diabetes. Diabetologia. 2008 Oct;51(10):1912-9. doi: 10.1007/s00125-008-1097-6. Epub 2008 Jul 29.