Physical Activity, Insulin Resistance and Function of Fat Tissue in the Offspring of Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring exercise, physical activity, insulin resistance, adipose tissue, gene expression
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
Sites / Locations
- University of Glasgow
Outcomes
Primary Outcome Measures
Insulin resistance at 8 weeks
Risk markers for cardiovascular disease/diabetes at 8 weeks
Adipose tissue gene expression at 8 weeks
Secondary Outcome Measures
Fitness at 8 weeks
Body composition/adiposity at 8 weeks
Full Information
NCT ID
NCT00268541
First Posted
December 21, 2005
Last Updated
April 19, 2007
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00268541
Brief Title
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
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
British Heart Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Diseases
Keywords
exercise, physical activity, insulin resistance, adipose tissue, gene expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Insulin resistance at 8 weeks
Title
Risk markers for cardiovascular disease/diabetes at 8 weeks
Title
Adipose tissue gene expression at 8 weeks
Secondary Outcome Measure Information:
Title
Fitness at 8 weeks
Title
Body composition/adiposity at 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason MR Gill, BSc MSc PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 8QQ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15533523
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.
Results Reference
background
PubMed Identifier
18663427
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.
Results Reference
derived
Learn more about this trial
Physical Activity, Insulin Resistance and Function of Fat Tissue in the Offspring of Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs