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

Cardiovascular Diseases Clinical Trial

Official title:

Physical Activity, Insulin Resistance and Adipose Tissue Gene Expression in the Offspring of Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268541
• Other study ID #: 03BI004
• Secondary ID: BHF Project Gran
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: April 19, 2007
• Start date: September 2004
• Est. completion date: February 2007

Study information

• Verified date: April 2007
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance at 8 weeks
Primary	Risk markers for cardiovascular disease/diabetes at 8 weeks
Primary	Adipose tissue gene expression at 8 weeks
Secondary	Fitness at 8 weeks
Secondary	Body composition/adiposity at 8 weeks