Type 2 Diabetes and ExerciseDIEGONCT01765894
Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls
An observational study of Type 2 Diabetes and Exercise, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Project description Research project title: Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls. Project description and objective Obesity is so widespread in Denmark that 47% of the population is classed as overweight (BMI>=25) and around 13% of the population is classed as obese… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes and Exercise
- What is being tested?
- 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Nov 2013
- Phase
- Observational
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: * 10 type 2 Diabetics without medication * 10 type 2 Diabetics on Metformin treatment * 10 matched healthy controls
Who may be able to join
- Age between 30 and 60 years old
- Maximum oxygen consumption between 20 and 50 ml/kg/minute
- BMI between 25 and 35 kg/m2
- Normal ECG
- Must have a stable weight throughout the last three months and have a normal balanced diet
- Can cycle for 45 minutes
Who cannot join
- For patients with type 2 diabetes: insulin treatment
- ECG that indicates cardiovascular disease
- Illness or medicine that may affect the results
- On-going weight loss diet
Trial locations and contacts
1 site in 1 country.
Denmark1 site
XLab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Official title: Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls.
Project description
Research project title:
Read more
Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.
Project description and objective
Obesity is so widespread in Denmark that 47% of the population is classed as overweight (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).
The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics are overweight) has led to many studies which look at different forms of exercise for this group, because weight loss may improve the diabetes and even defer the onset of the disorder and in doing so lower complications and increase long term survival.
For people who do not have type 2 diabetes, the work-induced increased sympathetic activity will lead to suppressed insulin secretion and increased glucagon secretion. This increases the endogenous glucose production from the liver and thus maintains a normal concentration of blood sugar in a physical training situation where the demand for glucose has increased.
The theory behind the project is that the mechanisms that help to increase glucose production in the liver during physical activity are weaker in type 2 diabetics, which can cause hypoglycaemia during and after physical exercise. In other words, we want to study the liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in relevant healthy control subjects.
Previous studies have indicated that this type of mechanism is not intact in type 2 diabetics; because the level of insulin does not fall as expected during or after physical training. However, there are no existing studies that measure the liver's glucose secretion using stable isotopes during prolonged moderate physical work. Measuring this will help to clarify our understanding of glucose homeostasis in type 2 diabetics.
This study is very relevant, because it may be expected that the preferred form of physical exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies also show that this form of physical exercise delivers health gains in terms of an improvement in insulin sensitivity and a reduction in the level of insulin.
The objective of this study is to determine if the level of blood glucose stays constant before, during and after physical training and to examine the liver's ability to secret glucose accordingly.
Read the detailed description
Design
A group of 20 people with type 2 diabetes and 10 control subjects are twice invited to the laboratory, respectively.
The type 2 diabetes group consist of 10 individuals being treated with metformin and 10 individuals who are not being treated with Metformin. The latter group may be diet-treated diabetics or diabetics who have stopped taking their oral antidiabetic agent for 72 hours before the day of the experiment.
On the first visit, the following is carried out:
- DXA scan, blood pressure measurement, determination of ECG and VO2-max on a cycleergometer
- Blood sample
- Questionnaire about everyday physical activity (I-PAQ)
On the second visit, the following is carried out:
- 3 days of carbohydrate loading prior to this day.(By diet recommendations).
- Insertion of arterial cannula, blood sample extraction.
- Insertion of venus cannula. Insertion of stable glucose isotopes over a period of 4.5 hours: 2,5 hours of relaxation in bed followed by 45 minutes of cycling on an exercise bicycle (during continued isotope infusion) at 60% of maximum heart rate reserve, which was measured on test day 1. Followed by relaxation with continued blood sampling and isotope infusion, one hour after cycling ceased.
Inclusion criteria
- Age between 30 and 60 years old,
- Maximum oxygen consumption between 20 and 50 ml/kg/minute,
- BMI between 25 and 35 kg/m2,
- Normal ECG,
- Must have a stable weight throughout the last three months and have a normal balanced diet,
- Can cycle for 45 minutes
Exclusion criteria
- For patients with type 2 diabetes: insulin treatment,
- ECG that indicates cardiovascular disease,
- Illness or medicine that may affect the results,
- On-going weight loss diet
DXA scan
Minimal radiation - The scan lasts from six to 10 minutes and the total radiation dose with measuring is below 0.01 mSv (millisievert). This is approximately equivalent to the natural daily background exposure.
Cycling test
Prior to this test, an ECG is carried out and the person is quizzed about his/her state of health. Regarding all experiments, there is quick access to doctors in the laboratory. The laboratory is equipped with a defibrillator.
Infusion with stable glucose isotopes
Stable glucose isotopes occur naturally in the body, though in much smaller amounts. They are not radioactive and require no special precautions.
Blood sampling
An arterial cannula is inserted, from which blood samples are subsequently taken. A sample is immediately analysed (ABL analyser) for glucose and lactate concentrations and blood gases, Hgb and Hct.
Other blood samples are processed on a centrifuge and the plasma is frozen at - 80 °C until it will be analysed.
The plasma is analysed to determine concentrations of:
Insulin, glucagon, cortisol, growth hormone (GH), adrenocorticotrophic hormone (ACTH),C-peptide, catecholamines , alanin, concentration of ketone, cholesterol free fatty acids,glycerol, glucose isotope (Ra) content before, during and after the cycling.
The biological material (in the form of plasma) will be stored in a freezer. When the experiment is completed, the material will be analysed in our laboratories. When all of the analysis has been carried out, any excess materials will be destroyed. All materials will be stored anonymously.
Ethical considerations
At all times, the study will be carried out in accordance with the latest of Helsinki and current Danish legislation.
Among other things, this includes voluntary participation and that test subjects can withdraw their consent at any time and without having to provide any explanation.
The study protocol and the written patient information will be submitted to the Research Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency will be informed. Patient inclusion cannot begin until a written approval has been received from both of these institutions. Both positive and, negative and inconclusive results must be published.
- Conditions
- Type 2 Diabetes and Exercise
- Being tested
- 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.
- Keywords
- glucose homeostasis, endogenous glucose production, moderate exercise, type 2 diabetes, metformin
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.Other
Also called exercise performed at 60% of heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| Normal glucose tolerance subjects | Healthy controls. If any medication then paused 3 days prior to test days. BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description. Receives: Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading. | |
| DM2 | Type 2 diabetics in diet treatment or type 2 diabetics who have paused their oral medication for 3 whole days.
Insulin treatment is an exclusion criteria. If any other medication then paused 3 days prior to test days.
BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description. Receives: Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading. | |
| DM2 + Metformin | Type 2 diabetics in metformin treatment. Insulin treatment is an exclusion criteria. If any other medication (besides from metformin) then paused 3 days prior to test days.
BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description Receives: Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment.
Glucose, hormones, substrates, metabolites and glucose-isotopes as mentioned in the protocol.
These end points will be measured on test day 2 only. Hormones and metabolites will be measured as AUC and total concentrations.
Measured: Observational study. Glucose homeostasis is tested one day only (in our Lab). Samples are taken 2,5 hours before, during and untill 1 hour after 45 minutes of exercise. Samples are taken every 5 minutes.
Secondary outcomes (4)
MAP during moderate exercise
MAP is continuously measured during exercise for 45 mins. (At 60% heart rate reserve)
Measured: 45 min of moderate exercise (test day 2).
vo2max
Is measured in all subjects prior to test day 2
Measured: one measurement each subject (test day 1)
DXA-values
DXA (fat%, lean body mass, BMD)is measured prior to test day 2
Measured: one measurement each subject (test day 1)
IL-6 and incretins
Effect of exercise on IL-6 and incretins. Described as AUC and total concentrations.
Measured: Observational study. Each test subject is tested for IL-6 and incretins one day only (in our Lab), where blood samples are taken continously during the test day every 5 minutes before, during and after exercise (test day 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes and ExerciseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Biomedical Sciences, XLab, Center of Healthy Aging
- Responsible party
- Principal investigator, Merethe Hansen, University of Copenhagen
- Investigators
- Flemming Dela, professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765894
- Sponsor's protocol ID
- H-1-2012-074
- Acronym
- DIEGO
- Status last verified
- Feb 2014
- First submitted
- 30 Nov 2012
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen M, Palsoe MK, Helge JW, Dela F. The effect of metformin on glucose homeostasis during moderate exercise. Diabetes Care. 2015 Feb;38(2):293-301. doi: 10.2337/dc14-1480. Epub 2014 Dec 2.
PubMed 25468944
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls.
- ClinicalTrials.gov ID
- NCT01765894
- Acronym / sponsor ID
- DIEGO / H-1-2012-074
- Conditions
- Type 2 Diabetes and Exercise
- Keywords
- glucose homeostasis, endogenous glucose production, moderate exercise, type 2 diabetes, metformin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Department of Biomedical Sciences, XLab, Center of Healthy Aging
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jan 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.
Project description
Research project title:
Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.
Project description and objective
Obesity is so widespread in Denmark that 47% of the population is classed as overweight (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).
The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics are overweight) has led to many studies which look at different forms of exercise for this group, because weight loss may improve the diabetes and even defer the onset of the disorder and in doing so lower complications and increase long term survival.
For people who do not have type 2 diabetes, the work-induced increased sympathetic activity will lead to suppressed insulin secretion and increased glucagon secretion. This increases the endogenous glucose production from the liver and thus maintains a normal concentration of blood sugar in a physical training situation where the demand for glucose has increased.
The theory behind the project is that the mechanisms that help to increase glucose production in the liver during physical activity are weaker in type 2 diabetics, which can cause hypoglycaemia during and after physical exercise. In other words, we want to study the liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in relevant healthy control subjects.
Previous studies have indicated that this type of mechanism is not intact in type 2 diabetics; because the level of insulin does not fall as expected during or after physical training. However, there are no existing studies that measure the liver's glucose secretion using stable isotopes during prolonged moderate physical work. Measuring this will help to clarify our understanding of glucose homeostasis in type 2 diabetics.
This study is very relevant, because it may be expected that the preferred form of physical exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies also show that this form of physical exercise delivers health gains in terms of an improvement in insulin sensitivity and a reduction in the level of insulin.
The objective of this study is to determine if the level of blood glucose stays constant before, during and after physical training and to examine the liver's ability to secret glucose accordingly.
Detailed description
Design
A group of 20 people with type 2 diabetes and 10 control subjects are twice invited to the laboratory, respectively.
The type 2 diabetes group consist of 10 individuals being treated with metformin and 10 individuals who are not being treated with Metformin. The latter group may be diet-treated diabetics or diabetics who have stopped taking their oral antidiabetic agent for 72 hours before the day of the experiment.
On the first visit, the following is carried out:
- DXA scan, blood pressure measurement, determination of ECG and VO2-max on a cycleergometer
- Blood sample
- Questionnaire about everyday physical activity (I-PAQ)
On the second visit, the following is carried out:
- 3 days of carbohydrate loading prior to this day.(By diet recommendations).
- Insertion of arterial cannula, blood sample extraction.
- Insertion of venus cannula. Insertion of stable glucose isotopes over a period of 4.5 hours: 2,5 hours of relaxation in bed followed by 45 minutes of cycling on an exercise bicycle (during continued isotope infusion) at 60% of maximum heart rate reserve, which was measured on test day 1. Followed by relaxation with continued blood sampling and isotope infusion, one hour after cycling ceased.
Inclusion criteria
- Age between 30 and 60 years old,
- Maximum oxygen consumption between 20 and 50 ml/kg/minute,
- BMI between 25 and 35 kg/m2,
- Normal ECG,
- Must have a stable weight throughout the last three months and have a normal balanced diet,
- Can cycle for 45 minutes
Exclusion criteria
- For patients with type 2 diabetes: insulin treatment,
- ECG that indicates cardiovascular disease,
- Illness or medicine that may affect the results,
- On-going weight loss diet
DXA scan
Minimal radiation - The scan lasts from six to 10 minutes and the total radiation dose with measuring is below 0.01 mSv (millisievert). This is approximately equivalent to the natural daily background exposure.
Cycling test
Prior to this test, an ECG is carried out and the person is quizzed about his/her state of health. Regarding all experiments, there is quick access to doctors in the laboratory. The laboratory is equipped with a defibrillator.
Infusion with stable glucose isotopes
Stable glucose isotopes occur naturally in the body, though in much smaller amounts. They are not radioactive and require no special precautions.
Blood sampling
An arterial cannula is inserted, from which blood samples are subsequently taken. A sample is immediately analysed (ABL analyser) for glucose and lactate concentrations and blood gases, Hgb and Hct.
Other blood samples are processed on a centrifuge and the plasma is frozen at - 80 °C until it will be analysed.
The plasma is analysed to determine concentrations of:
Insulin, glucagon, cortisol, growth hormone (GH), adrenocorticotrophic hormone (ACTH),C-peptide, catecholamines , alanin, concentration of ketone, cholesterol free fatty acids,glycerol, glucose isotope (Ra) content before, during and after the cycling.
The biological material (in the form of plasma) will be stored in a freezer. When the experiment is completed, the material will be analysed in our laboratories. When all of the analysis has been carried out, any excess materials will be destroyed. All materials will be stored anonymously.
Ethical considerations
At all times, the study will be carried out in accordance with the latest of Helsinki and current Danish legislation.
Among other things, this includes voluntary participation and that test subjects can withdraw their consent at any time and without having to provide any explanation.
The study protocol and the written patient information will be submitted to the Research Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency will be informed. Patient inclusion cannot begin until a written approval has been received from both of these institutions. Both positive and, negative and inconclusive results must be published.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal glucose tolerance subjects | – | Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.Healthy controls. If any medication then paused 3 days prior to test days. BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description. |
| DM2 | – | Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.Type 2 diabetics in diet treatment or type 2 diabetics who have paused their oral medication for 3 whole days. Insulin treatment is an exclusion criteria. If any other medication then paused 3 days prior to test days. BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description. |
| DM2 + Metformin | – | Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.Type 2 diabetics in metformin treatment. Insulin treatment is an exclusion criteria. If any other medication (besides from metformin) then paused 3 days prior to test days. BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * 10 type 2 Diabetics without medication * 10 type 2 Diabetics on Metformin treatment * 10 matched healthy controls
Key inclusion criteria (6 listed)
- Age between 30 and 60 years old
- Maximum oxygen consumption between 20 and 50 ml/kg/minute
- BMI between 25 and 35 kg/m2
- Normal ECG
- Must have a stable weight throughout the last three months and have a normal balanced diet
Key exclusion criteria (4 listed)
- For patients with type 2 diabetes: insulin treatment
- ECG that indicates cardiovascular disease
- Illness or medicine that may affect the results
- On-going weight loss diet
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 |
|---|---|---|
| 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.Also: exercise performed at 60% of heart rate reserve. | Other | DM2, DM2 + Metformin, Normal glucose tolerance subjects |
Primary outcome
Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment.
Time frame: Observational study. Glucose homeostasis is tested one day only (in our Lab). Samples are taken 2,5 hours before, during and untill 1 hour after 45 minutes of exercise. Samples are taken every 5 minutes.
Glucose, hormones, substrates, metabolites and glucose-isotopes as mentioned in the protocol. These end points will be measured on test day 2 only. Hormones and metabolites will be measured as AUC and total concentrations.
4 secondary outcomes
MAP during moderate exercise
Time frame: 45 min of moderate exercise (test day 2).
vo2max
Time frame: one measurement each subject (test day 1)
DXA-values
Time frame: one measurement each subject (test day 1)
IL-6 and incretins
Time frame: Observational study. Each test subject is tested for IL-6 and incretins one day only (in our Lab), where blood samples are taken continously during the test day every 5 minutes before, during and after exercise (test day 2).
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 24 Feb 2014.
- Derived from this study: PubMed 25468944Hansen M, Palsoe MK, Helge JW, Dela F. The effect of metformin on glucose homeostasis during moderate exercise. Diabetes Care. 2015 Feb;38(2):293-301. doi: 10.2337/dc14-1480. Epub 2014 Dec 2.
Related trials for Type 2 Diabetes and Exercise
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Poor Glycemic Control Despite Lifestyle Intervention
Diabetes Mellitus, Type 2
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Flemming Dela, professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Exercise, run by University of Copenhagen at 1 site in Denmark.
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 4 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 24 Feb 2014. 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 Denmark. 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?
Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment. (time frame: Observational study. Glucose homeostasis is tested one day only (in our Lab). Samples are taken 2,5 hours before, during and untill 1 hour after 45 minutes of exercise. Samples are taken every 5 minutes.). 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 NCT01765894, which also lists 1 linked publication.
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 24 Feb 2014.