Diabetes Mellitus, Type 2CGMSexerciseNCT00887094
Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes
A study testing Acute aerobic exercise and Acute aerobic-resistance exercise in people with Diabetes Mellitus, Type 2 and Treatment, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Treatment, Exercise
- What is being tested?
- Acute aerobic exercise and Acute aerobic-resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Apr 2011
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients treated with diet and metformin, 35-65 years old
Who cannot join
- Type 1 diabetic patients
- Treatment with insulin or sulphonylureas or glitazones
- Proliferative retinopathy
- Severe autonomic neuropathy
- Coronary artery disease
- Baseline fasting plasma glucose>200 mg/dl
Show all 11Show fewer
- Peripheral artery disease
- Amputation
- Heart failure
- Diabetic nephropathy
- Renal failure
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Acute and Subacute Effects of Aerobic Training vs Aerobic/Resistance Training Upon Glucose Profile Evaluated Through Continuous Glucose Monitoring System in Type 2 Diabetes
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
Read the detailed description
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2, Treatment, Exercise
- Being tested
- Acute aerobic exercise, Acute aerobic-resistance exercise
- Keywords
- Diabetes mellitus, Exercise, Endurance, Resistance, Continuous glucose monitoring system
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute aerobic exerciseBehavioural
Also called There are no other names
Aerobic exercise (on a cycle ergometer, for 50 min)
Acute aerobic-resistance exerciseBehavioural
Also called There are no other names
Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | One bout of aerobic physical training will be performed on a cycle ergometer for 50 min Receives: Behavioral: Acute aerobic exercise |
| Aerobic-resistance exercise | Experimental | One bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total) Receives: Behavioral: Acute aerobic-resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy.
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Beatriz Schaan, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887094
- Sponsor's protocol ID
- 08-180
- Acronym
- CGMSexercise
- Status last verified
- Aug 2011
- First submitted
- 22 Apr 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Figueira FR, Umpierre D, Casali KR, Tetelbom PS, Henn NT, Ribeiro JP, Schaan BD. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial. PLoS One. 2013;8(3):e57733. doi: 10.1371/journal.pone.0057733. Epub 2013 Mar 11.
PubMed 23536769Figueira FR, Umpierre D, Ribeiro JP, Tetelbom PS, Henn NT, Esteves JF, Schaan BD. Accuracy of continuous glucose monitoring system during exercise in type 2 diabetes. Diabetes Res Clin Pract. 2012 Dec;98(3):e36-9. doi: 10.1016/j.diabres.2012.09.033. Epub 2012 Oct 4.
PubMed 23041227
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Subacute Effects of Aerobic Training vs Aerobic/Resistance Training Upon Glucose Profile Evaluated Through Continuous Glucose Monitoring System in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00887094
- Acronym / sponsor ID
- CGMSexercise / 08-180
- Conditions
- Diabetes Mellitus, Type 2, Treatment, Exercise
- Keywords
- Diabetes mellitus, Exercise, Endurance, Resistance, Continuous glucose monitoring system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Apr 2009 (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.
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
Detailed description
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Acute aerobic exerciseOne bout of aerobic physical training will be performed on a cycle ergometer for 50 min |
| Aerobic-resistance exercise | Experimental | Behavioral: Acute aerobic-resistance exerciseOne bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients treated with diet and metformin, 35-65 years old
Key exclusion criteria (11 listed)
- Type 1 diabetic patients
- Treatment with insulin or sulphonylureas or glitazones
- Proliferative retinopathy
- Severe autonomic neuropathy
- Coronary artery disease
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 |
|---|---|---|
| Acute aerobic exerciseAlso: There are no other namesAerobic exercise (on a cycle ergometer, for 50 min) | Behavioural | Aerobic exercise |
| Acute aerobic-resistance exerciseAlso: There are no other namesAerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total) | Behavioural | Aerobic-resistance exercise |
Primary outcome
Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy.
Time frame: 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Derived from this study: PubMed 23536769Figueira FR, Umpierre D, Casali KR, Tetelbom PS, Henn NT, Ribeiro JP, Schaan BD. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial. PLoS One. 2013;8(3):e57733. doi: 10.1371/journal.pone.0057733. Epub 2013 Mar 11.
- Derived from this study: PubMed 23041227Figueira FR, Umpierre D, Ribeiro JP, Tetelbom PS, Henn NT, Esteves JF, Schaan BD. Accuracy of continuous glucose monitoring system during exercise in type 2 diabetes. Diabetes Res Clin Pract. 2012 Dec;98(3):e36-9. doi: 10.1016/j.diabres.2012.09.033. Epub 2012 Oct 4.
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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.
Beatriz Schaan, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute aerobic exercise and Acute aerobic-resistance exercise in people with Diabetes Mellitus, Type 2 and Treatment, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 11 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 4 Aug 2011. 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 Brazil. 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?
Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy. (time frame: 24h). 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 NCT00887094, 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 4 Aug 2011.