Physical Activity, Insulin Resistance and Function of Fat Tissue in the Offspring of Patients With Type 2 Diabetes

NCT ID: NCT00268541

Last Updated: 2007-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-02-28

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.

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Principal Investigators

Jason MR Gill, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

University of Glasgow

Glasgow, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 15533523 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18663427 (View on PubMed)

Other Identifiers

BHF Project Grant PG/03/145

Identifier Type: -

Identifier Source: secondary_id

03BI004

Identifier Type: -

Identifier Source: org_study_id