Prediabetic StateEFFORTNCT01941277
Effect of Exercise on Insulin Resistance
A study testing Current Recommendations Exercise Group and Intensive Exercise Group in people with Prediabetic State, run by Alere San Diego at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Current Recommendations Exercise Group and Intensive Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2014to Mar 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years.
- Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment);
- Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ≤ 125 mg/dL (6.0-6.9 mmol/L)
- HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
- 2-hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
- No clinically significant adverse exercise response during the maximal graded exercise test
Who cannot join
- Weight loss diet program or weight change (>10%) within the past 6 months
- Daily physical activity of >10,000 steps per day (as measured during the interval between visits 1 and 2)
- Participates in deliberate structured exercise
- Pregnant or intending to become pregnant
- Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
- Unwillingness to participate in all study procedures
Show all 20Show fewer
- Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
- BMI greater than 40 kg/m2
- Concurrent participation in another lifestyle modification trial
- Diagnosis of diabetes based on any one of the following criteria:
- Fasting plasma or whole blood glucose ≥ 126 mg/dL (7 mmol/L)
- HbA1c of >6.5% (>47 mmol/mol)
- 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an OGTT
- Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:
- Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months
- Current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications
- Current use of beta blockers (beta-adrenergic blocking agents)
- Current or previous use (within the past year) of the following medications: diabetes related medications or insulin; metformin; growth hormone; glucagon; dipeptidyl peptidase-4(DPP-4) inhibitors (saxagliptin, stigagliptin); glucagon-Like Peptide-1(GLP-1) mimetics (exenatide, liraglutide); sulfonylurea medication or other potential confounding medications
- Medical conditon which predetermines insulin resistance (e.g. Marfan syndrome / severe Polycystic ovary syndrome (PCOS) / Cushing syndrome etc.).
- Fasting triglycerides > 1000 mg/dL.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Manchester University
Manchester, M23 9QZ
Move Lab
Newcastle upon Tyne, NE1 7RU
About this study
The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes).
It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.
- Conditions
- Prediabetic State
- Being tested
- Current Recommendations Exercise Group, Intensive Exercise Group
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Recommendations Exercise GroupBehavioural
Intensive Exercise GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intensive Exercise Group | Experimental | Behavioral Receives: Behavioral: Intensive Exercise Group |
| Current Recommendations Exercise Group | Experimental | Behavioral Receives: Behavioral: Current Recommendations Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A decrease in Insulin Resistance (IR) as measured by a change in IR.
Measured: change between baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alere San Diego
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rick San George, PhD, Study director, Alere San DiegoMichael Trenell, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941277
- Sponsor's protocol ID
- BSTE-0902
- Acronym
- EFFORT
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2013
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Insulin Resistance
- ClinicalTrials.gov ID
- NCT01941277
- Acronym / sponsor ID
- EFFORT / BSTE-0902
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding withdrawn
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alere San DiegoIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes).
It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Exercise Group | Experimental | Behavioral: Intensive Exercise GroupBehavioral |
| Current Recommendations Exercise Group | Experimental | Behavioral: Current Recommendations Exercise GroupBehavioral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years.
- Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment);
- No clinically significant adverse exercise response during the maximal graded exercise test
Key exclusion criteria (20 listed)
- Weight loss diet program or weight change (>10%) within the past 6 months
- Daily physical activity of >10,000 steps per day (as measured during the interval between visits 1 and 2)
- Participates in deliberate structured exercise
- Pregnant or intending to become pregnant
- Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current Recommendations Exercise Group | Behavioural | Current Recommendations Exercise Group |
| Intensive Exercise Group | Behavioural | Intensive Exercise Group |
Primary outcome
A decrease in Insulin Resistance (IR) as measured by a change in IR.
Time frame: change between baseline and 6 weeks
Results and safety
The study was stopped early (reason given: funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Related trials for Prediabetic State
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick San George, PhD study director
Alere San Diego
Michael Trenell, PhD principal investigator
Newcastle University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current Recommendations Exercise Group and Intensive Exercise Group in people with Prediabetic State, run by Alere San Diego at 2 sites 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: funding withdrawn). Results are not available in the source record.
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?
A decrease in Insulin Resistance (IR) as measured by a change in IR. (time frame: change between baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.