ObesityNCT02620670
Evaluation of the Effect of Moderate-intensity Physical Activity on Glycemic Variability
A study testing Physical activity of moderate intensity for 3 days in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Obesity is a major public health problem on the world and Mexico too, in addition the obesity develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Physical activity of moderate intensity for 3 days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- 15 Apr 2015to 27 Dec 2017
- 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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: male and female.
- Age: 30-40 years.
- Diagnosis of obesity and normal weight according to WHO:
- Individuals with normal weight or BMI ≥ 18.5 to 24.9 kg / m2. Individuals with obesity or BMI ≥ 30 to 39.9 kg / m2.
- Diagnosis absence of visceral obesity according to WHO: Normal Weight; waist circumference: Women <80 cm and men <90 cm.
- Diagnosis of visceral obesity according to WHO: waist circumference: Women and men ≥ 80 cm ≥ 90 cm.
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- What are sedentary during the past three months. Individuals committed in 15-30 minutes of physical activity exclusively by at least 3 times a week at most.
- No change in the oral glucose tolerance according to the ADA:
- or fasting glucose <100 mg / dL and afterload glucose <140 mg / dL.
- written informed consent.
Who cannot join
- Women pregnant or lactating.
- Diagnosis of DM according to the ADA. Fasting glucose: ≥ 126 mg / dL glucose and afterload: ≥ 140 mg / dL.
- Thyroid disease and / or hypertension.
- Diagnosis of metabolic syndrome.
- Consumption of oral agents or other medicines and supplements with proven properties that modify the behavior of glucose.
- Liver enzymes: GOT and GPT concentrations twice normal.
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- Changes in GFR according to the Cockcroft and Gault, with levels below 60 mL / min / 1.73 m2, which is suggestive of chronic kidney disease.
- Changes in serum lipid levels:
- Total cholesterol <200 mg / dL Triglycerides <150 mg / dL HDL-C > 60 mg / dL or LDL-C <130 mg / dL
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Evaluation of the Effect of Moderate-intensity Physical Activity on Glycemic Variability in Individuals With Visceral Obesity and Normal Weight Without Changes in Glucose Tolerance
Obesity is a major public health problem on the world and Mexico too, in addition the obesity develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). So the phenomenon of obesity is studied in many investigations to know their causes, prevention and treatment.
Participation of body fat and especially in the visceral area is well documented in the appearance of T2DM; however, it is quite interesting that found that not all individuals with visceral obesity have impaired glucose tolerance, prediabetes or T2DM; but they are presented as normoglycemic individuals with obesity.
Currently, it is recognized that physical activity influences the concentrations of plasma glucose, and promoting their utilization in peripheral tissues, to be used as an energy source, through the regulation of glucose transporters in tissues such as the muscle, so might influence the glycemic variability, and therefore is of interest to this study to evaluate the effect of physical activity of moderate intensity on the glycemic variability of individuals with visceral obesity and normal weight without alterations in tolerance glucose.
Read the detailed description
A quasi-experimental longitudinal and analytical study, consisting of two groups were carried out: a group of individuals with visceral obesity and other individuals with normal weight; both groups with no alteration in glucose tolerance. The world of work will be patients 30-40 years of age; for the group of individuals with visceral obesity body mass index (BMI) 30.0-39.9 kg/m2 and a waist circumference greater than 80 cm in women and 90 cm for men, and for the group of individuals with normal weight BMI 18.5-24.9 kg/m2 with lower waist circumference of 80 cm for women and 90 cm for men.
It will be confirmed by a curve oral glucose tolerance, that individuals do not have impaired glucose tolerance at baseline; likewise, they are determined serum levels of urea, creatinine, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (SGPT) and lipid levels (total cholesterol, triglycerides [TG], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C] and very low density lipoprotein [VLDL]). BMI, waist circumference and body weight distribution (body fat percentage, visceral fat level, weight, lean body mass and percentage of water): On the other hand, at the beginning and end of the study the following determinations were obtained.
The study will last for 6 days. To measure glycemic variability on the first day they place a system of continuous glucose payment (MCG) through the iPro ™ 2 system (Medtronic MiniMed, Northridge) which determine interstitial glucose levels every five minutes. During the first 3 days the individual volunteer perform their usual activities, and three days later made moderate intensity physical activity for 30 minutes in the morning with fasting for 8-12 hours.
From the data obtained from MCG the mean amplitude of glucose excursions (MAGE), which will assess glycemic variability and area under the curve (AUC) was calculated. For statistical analysis, the Mann-Whitney U test, Fisher's exact test, Wilcoxon and linear regression was used. It is considered significant difference for p <0.05.
- Conditions
- Obesity
- Being tested
- Physical activity of moderate intensity for 3 days
- Keywords
- Physical Activity, Glycemic Variability
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity of moderate intensity for 3 daysBehavioural
The intervencion consist in a moderate-intensity physical activity exercise is a heart rate between 60 and 70% of maximum heart beats per minute for at least 30 minutes for three days
| Study group | Role | What they receive |
|---|---|---|
| Individuals with obesity | Active comparator | Body mass index (BMI) is 30.0 to 39.9 kg / m2 and a waist circumference greater than 80 cm in women and 90 cm for men Physical activity of moderate intensity for 3 days Receives: Behavioral: Physical activity of moderate intensity for 3 days |
| Individuals with normal weight | Active comparator | Body mass index BMI is 18.5 to 24.9 kg / m2 with lower waist circumference of 80 cm for women and 90 cm for men Physical activity of moderate intensity for 3 days Receives: Behavioral: Physical activity of moderate intensity for 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amplitude of glucose excusions (MAGE)
Before and after the physical activity of moderate intensity outpatient daily glucose monitor iPro ™ 2
Measured: 6 days
Secondary outcomes (3)
Body mass index
Before and after the physical activity of moderate intensity
Measured: 6 days
Waist circumference
Before and after the physical activity of moderate intensity
Measured: 6 days
Postprandial glucose
Before and after the physical activity of moderate intensity outpatient daily glucose monitor iPro ™ 2
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start15 Apr 2015
- Primary completion1 Oct 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Martínez-Abundis, University of Guadalajara
- Investigators
- Esperanza Martínez-Abundis, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620670
- Sponsor's protocol ID
- EAFVG
- Status last verified
- Jan 2018
- First submitted
- 10 Sep 2015
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Moderate-intensity Physical Activity on Glycemic Variability in Individuals With Visceral Obesity and Normal Weight Without Changes in Glucose Tolerance
- ClinicalTrials.gov ID
- NCT02620670
- Acronym / sponsor ID
- EAFVG
- Conditions
- Obesity
- Keywords
- Physical Activity, Glycemic Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 3 Dec 2015 (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.
Obesity is a major public health problem on the world and Mexico too, in addition the obesity develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). So the phenomenon of obesity is studied in many investigations to know their causes, prevention and treatment.
Participation of body fat and especially in the visceral area is well documented in the appearance of T2DM; however, it is quite interesting that found that not all individuals with visceral obesity have impaired glucose tolerance, prediabetes or T2DM; but they are presented as normoglycemic individuals with obesity.
Currently, it is recognized that physical activity influences the concentrations of plasma glucose, and promoting their utilization in peripheral tissues, to be used as an energy source, through the regulation of glucose transporters in tissues such as the muscle, so might influence the glycemic variability, and therefore is of interest to this study to evaluate the effect of physical activity of moderate intensity on the glycemic variability of individuals with visceral obesity and normal weight without alterations in tolerance glucose.
Detailed description
A quasi-experimental longitudinal and analytical study, consisting of two groups were carried out: a group of individuals with visceral obesity and other individuals with normal weight; both groups with no alteration in glucose tolerance. The world of work will be patients 30-40 years of age; for the group of individuals with visceral obesity body mass index (BMI) 30.0-39.9 kg/m2 and a waist circumference greater than 80 cm in women and 90 cm for men, and for the group of individuals with normal weight BMI 18.5-24.9 kg/m2 with lower waist circumference of 80 cm for women and 90 cm for men.
It will be confirmed by a curve oral glucose tolerance, that individuals do not have impaired glucose tolerance at baseline; likewise, they are determined serum levels of urea, creatinine, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (SGPT) and lipid levels (total cholesterol, triglycerides [TG], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C] and very low density lipoprotein [VLDL]). BMI, waist circumference and body weight distribution (body fat percentage, visceral fat level, weight, lean body mass and percentage of water): On the other hand, at the beginning and end of the study the following determinations were obtained.
The study will last for 6 days. To measure glycemic variability on the first day they place a system of continuous glucose payment (MCG) through the iPro ™ 2 system (Medtronic MiniMed, Northridge) which determine interstitial glucose levels every five minutes. During the first 3 days the individual volunteer perform their usual activities, and three days later made moderate intensity physical activity for 30 minutes in the morning with fasting for 8-12 hours.
From the data obtained from MCG the mean amplitude of glucose excursions (MAGE), which will assess glycemic variability and area under the curve (AUC) was calculated. For statistical analysis, the Mann-Whitney U test, Fisher's exact test, Wilcoxon and linear regression was used. It is considered significant difference for p <0.05.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with obesity | Active comparator | Behavioral: Physical activity of moderate intensity for 3 daysBody mass index (BMI) is 30.0 to 39.9 kg / m2 and a waist circumference greater than 80 cm in women and 90 cm for men Physical activity of moderate intensity for 3 days |
| Individuals with normal weight | Active comparator | Behavioral: Physical activity of moderate intensity for 3 daysBody mass index BMI is 18.5 to 24.9 kg / m2 with lower waist circumference of 80 cm for women and 90 cm for men Physical activity of moderate intensity for 3 days |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Gender: male and female.
- Age: 30-40 years.
- Diagnosis of obesity and normal weight according to WHO:
- Individuals with normal weight or BMI ≥ 18.5 to 24.9 kg / m2. Individuals with obesity or BMI ≥ 30 to 39.9 kg / m2.
- Diagnosis absence of visceral obesity according to WHO: Normal Weight; waist circumference: Women <80 cm and men <90 cm.
Key exclusion criteria (9 listed)
- Women pregnant or lactating.
- Diagnosis of DM according to the ADA. Fasting glucose: ≥ 126 mg / dL glucose and afterload: ≥ 140 mg / dL.
- Thyroid disease and / or hypertension.
- Diagnosis of metabolic syndrome.
- Consumption of oral agents or other medicines and supplements with proven properties that modify the behavior of glucose.
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 |
|---|---|---|
| Physical activity of moderate intensity for 3 daysThe intervencion consist in a moderate-intensity physical activity exercise is a heart rate between 60 and 70% of maximum heart beats per minute for at least 30 minutes for three days | Behavioural | Individuals with normal weight, Individuals with obesity |
Primary outcome
Mean amplitude of glucose excusions (MAGE)
Time frame: 6 days
Before and after the physical activity of moderate intensity outpatient daily glucose monitor iPro ™ 2
3 secondary outcomes
Body mass index
Time frame: 6 days
Waist circumference
Time frame: 6 days
Postprandial glucose
Time frame: 6 days
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 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Esperanza Martínez-Abundis, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity of moderate intensity for 3 days in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
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 10 inclusion and 9 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 30 Apr 2018. 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 Mexico. 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?
Mean amplitude of glucose excusions (MAGE) (time frame: 6 days). 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 30 Apr 2018.