NCT00268541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

December 21, 2005

Last Update Submit

April 19, 2007

Conditions

Type 2 Diabetes MellitusCardiovascular Diseases

Keywords

exercisephysical activityinsulin resistanceadipose tissuegene expression

Outcome Measures

Primary Outcomes (3)

  • Insulin resistance at 8 weeks

  • Risk markers for cardiovascular disease/diabetes at 8 weeks

  • Adipose tissue gene expression at 8 weeks

Secondary Outcomes (2)

  • Fitness at 8 weeks

  • Body composition/adiposity at 8 weeks

Interventions

Physical activityBEHAVIORAL

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 15533523BACKGROUND

  • 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.

    PMID: 18663427DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesMotor ActivityInsulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorHyperinsulinism

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jason MR Gill, BSc MSc PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

September 1, 2004

Study Completion

February 1, 2007

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

GB(1)