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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00268541
First Posted: December 22, 2005
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Heart Foundation
Information provided by:
NHS Greater Glasgow and Clyde
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Cardiovascular Diseases Behavioral: Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity, Insulin Resistance and Adipose Tissue Gene Expression in the Offspring of Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

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

Estimated Enrollment: 80
Study Start Date: September 2004
Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268541


Locations
United Kingdom
University of Glasgow
Glasgow, United Kingdom, G12 8QQ
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
British Heart Foundation
Investigators
Principal Investigator: Jason MR Gill, BSc MSc PhD University of Glasgow
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00268541     History of Changes
Other Study ID Numbers: 03BI004
BHF Project Grant PG/03/145
First Submitted: December 21, 2005
First Posted: December 22, 2005
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by NHS Greater Glasgow and Clyde:
exercise
physical activity
insulin resistance
adipose tissue
gene expression

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs