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Type 2 Diabetes MellitusNCT00268541

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

A study testing Physical activity in people with Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Physical activity
How many people
80 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2004to Feb 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Glasgow

    Glasgow, G12 8QQ

Other trials in United Kingdom

About this study

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

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.

Being tested
Physical activity
Keywords
exercise, physical activity, insulin resistance, adipose tissue, gene expression
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Motor Activity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin resistance at 8 weeks

  2. Risk markers for cardiovascular disease/diabetes at 8 weeks

  3. Adipose tissue gene expression at 8 weeks

Secondary outcomes (2)

  1. Fitness at 8 weeks

  2. Body composition/adiposity at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startSep 2004
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268541
Sponsor's protocol ID
03BI004
Other IDs
BHF Project Grant PG/03/145
Status last verified
Apr 2007
First submitted
21 Dec 2005
Last updated
20 Apr 2007
Results posted
No

Publications

  • 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.

    PubMed 15533523

  • 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.

    PubMed 18663427

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin resistance at 8 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268541, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.

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