Roux-en-Y Gastric BypassNCT03478098
Meal Glycaemic Index and Exercise After Gastric Bypass
A study testing Low GI mealtest, Low GI mealtest and subsequent exercise and High GI mealtest in people with Roux-en-Y Gastric Bypass and Obesity, run by Kirstine Nyvold Bojsen-Moeller at 1 site in Denmark.
Trial summary
The study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Roux-en-Y Gastric Bypass, Obesity
- What is being tested?
- Low GI mealtest, Low GI mealtest and subsequent exercise and High GI mealtest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2018to 1 Mar 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergone Roux-en-Y gastric bypass (RYGB) without complications at least 12 months prior to inclusion.
- Achieved > 50% Excess BMI Loss
- Weight stability (no fluctuations over ± 5 kg the last 3 months)
- HBA1c < 48 mmol/mol before and after surgery without the use of anti-diabetic medication
- The participant must be able to ingest the meals
- Matched with the RYGB patients on gender, age (± 5 years), menopausal state (pre- versus post-menopausal) and BMI (± 3 points).
- Weight stable ( ± 5 kg during 3 months)
- HBA1c < 48 mmol/mol
Who cannot join
- Low hemoglobin levels (< 6.5 mM)
- Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
- Dysregulated thyroid gland affection
- The use of medication which affects heart frequency (i.e. Beta-blockers)
- Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).
- Control group:
- Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre Hospital
Hvidovre, DK-2650
About this study
Official title: The Importance of Glycaemic Index and Exercise on Postprandial Glucose Excursions and Gut Hormone Secretion Following Roux-en-Y Gastric Bypass
The study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects.
- Conditions
- Roux-en-Y Gastric Bypass, Obesity
- Being tested
- Low GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest, High GI mealtest and subsequent exercise
- Keywords
- Gut hormones, Glucose excursions
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GI mealtestOther
Meal with low glycaemic index (GI) is consumed over 20 min
Low GI mealtest and subsequent exerciseOther
Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
High GI mealtestOther
Meal with high glycaemic index (GI) is consumed over 20 min
High GI mealtest and subsequent exerciseOther
Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
| Study group | Role | What they receive |
|---|---|---|
| 10 Roux-en-Y Gastric Bypass patients | Experimental | 4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise Receives: Other: Low GI mealtest; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise |
| 10 control subjects | Experimental | 4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise Receives: Other: Low GI mealtest; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention
Comparison of nadir plasma glucose in response to an acute bout of exercise internally in groups a) RYGB and b) control group
Measured: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Impact of glycaemic index on nadir plasma glucose within groups for each intervention
Comparison of nadir plasma glucose in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group
Measured: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Secondary outcomes (17)
Impact of acute bout of exercise on AUC glucose within groups
Comparison of plasma glucose excursions in response to an acute bout of exercise internally in groups a) RYGB and b) control group determined by differences in area under curve (AUC)
Measured: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of acute bout of exercise on delta-fasting-peak glucose within groups
Comparison of plasma glucose excursions in response to an acute bout of exercise internally in groups a) RYGB and b) control group determined by delta-fasting-to-peak concentrations of glucose
Measured: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of glycaemic index on AUC glucose within groups
Comparison of plasma glucose excursions in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group determined by differences in area-under-the-curve of glucose
Measured: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of glycaemic index on delta-fasting-peak glucose within groups
Comparison of plasma glucose excursions in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group determined by differences in delta-fasting-peak glucose
Measured: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC
AUC GLP-1 will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC for time concentration curve of GLP-1 at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in peak concentration
Peak GLP-1 will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values
decremental AUC of ghrelin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Decremental AUC for the time concentration curve of ghrelin at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC
AUC PYY will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration
Peak PYY will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC
AUC GIP will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration
Peak GIP will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC
AUC glucagon will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC
AUC lactate will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC of the time-concentration curve of lactate at 0, 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration
Peak lactate will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC
AUC insulin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration
Peak insulin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group
Measured: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on ad libitum food intake within the groups determined by differences in ingested amount of ad libitum meal in grams
Grams of ad libitum food intake. Food will be served at 240 minutes after fixed breakfast meal
Measured: at 240 min following ingestion of test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux-en-Y Gastric BypassStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirstine Nyvold Bojsen-Moeller
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
- Investigators
- Kirstine N Bojsen-Moller, MD, PhD, Principal investigator, Department of Endocrinology, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478098
- Sponsor's protocol ID
- ExRYGB
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Glycaemic Index and Exercise on Postprandial Glucose Excursions and Gut Hormone Secretion Following Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03478098
- Acronym / sponsor ID
- ExRYGB
- Conditions
- Roux-en-Y Gastric Bypass, Obesity
- Keywords
- Gut hormones, Glucose excursions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kirstine Nyvold Bojsen-MoellerUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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 study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Roux-en-Y Gastric Bypass patients | Experimental | Other: Low GI mealtest, Other: Low GI mealtest and subsequent exercise, Other: High GI mealtest, Other: High GI mealtest and subsequent exercise4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise |
| 10 control subjects | Experimental | Other: Low GI mealtest, Other: Low GI mealtest and subsequent exercise, Other: High GI mealtest, Other: High GI mealtest and subsequent exercise4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Undergone Roux-en-Y gastric bypass (RYGB) without complications at least 12 months prior to inclusion.
- Achieved > 50% Excess BMI Loss
- Weight stability (no fluctuations over ± 5 kg the last 3 months)
- HBA1c < 48 mmol/mol before and after surgery without the use of anti-diabetic medication
- The participant must be able to ingest the meals
Key exclusion criteria (7 listed)
- Low hemoglobin levels (< 6.5 mM)
- Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
- Dysregulated thyroid gland affection
- The use of medication which affects heart frequency (i.e. Beta-blockers)
- Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).
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 |
|---|---|---|
| Low GI mealtestMeal with low glycaemic index (GI) is consumed over 20 min | Other | 10 Roux-en-Y Gastric Bypass patients, 10 control subjects |
| Low GI mealtest and subsequent exerciseMeal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min | Other | 10 Roux-en-Y Gastric Bypass patients, 10 control subjects |
| High GI mealtestMeal with high glycaemic index (GI) is consumed over 20 min | Other | 10 Roux-en-Y Gastric Bypass patients, 10 control subjects |
| High GI mealtest and subsequent exerciseMeal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min | Other | 10 Roux-en-Y Gastric Bypass patients, 10 control subjects |
Primary outcome
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention
Time frame: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Comparison of nadir plasma glucose in response to an acute bout of exercise internally in groups a) RYGB and b) control group
Impact of glycaemic index on nadir plasma glucose within groups for each intervention
Time frame: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Comparison of nadir plasma glucose in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group
17 secondary outcomes
Impact of acute bout of exercise on AUC glucose within groups
Time frame: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of acute bout of exercise on delta-fasting-peak glucose within groups
Time frame: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of glycaemic index on AUC glucose within groups
Time frame: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of glycaemic index on delta-fasting-peak glucose within groups
Time frame: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC
Time frame: AUC for time concentration curve of GLP-1 at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in peak concentration
Time frame: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values
Time frame: Decremental AUC for the time concentration curve of ghrelin at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC
Time frame: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration
Time frame: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC
Time frame: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration
Time frame: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC
Time frame: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC
Time frame: AUC of the time-concentration curve of lactate at 0, 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration
Time frame: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC
Time frame: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration
Time frame: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on ad libitum food intake within the groups determined by differences in ingested amount of ad libitum meal in grams
Time frame: at 240 min following ingestion of test meal
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 15 Jun 2023.
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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.
Kirstine N Bojsen-Moller, MD, PhD principal investigator
Department of Endocrinology, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low GI mealtest, Low GI mealtest and subsequent exercise and High GI mealtest in people with Roux-en-Y Gastric Bypass and Obesity, run by Kirstine Nyvold Bojsen-Moeller 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 8 inclusion and 7 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 15 Jun 2023. 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?
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention (time frame: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal). The study lists 2 primary outcomes in all. 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 15 Jun 2023.