Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Effect of Moderate-intensity Physical Activity on Glycemic Variability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02620670
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Physical activity of moderate intensity for 3 days Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 15, 2015
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : December 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Individuals with obesity
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
Behavioral: Physical activity of moderate intensity for 3 days
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

Active Comparator: Individuals with normal weight
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
Behavioral: Physical activity of moderate intensity for 3 days
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: 6 days ]
    Before and after the physical activity of moderate intensity

  2. Waist circumference [ Time Frame: 6 days ]
    Before and after the physical activity of moderate intensity

  3. Postprandial glucose [ Time Frame: 6 days ]
    Before and after the physical activity of moderate intensity outpatient daily glucose monitor iPro ™ 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

  • 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.

Exclusion Criteria:

  • 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.
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620670


Locations
Layout table for location information
Mexico
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
Layout table for investigator information
Principal Investigator: Esperanza Martínez-Abundis, PhD Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Layout table for additonal information
Responsible Party: Esperanza Martínez-Abundis, PhD. Esperanza Martínez-Abundis, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02620670     History of Changes
Other Study ID Numbers: EAFVG
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Physical Activity
Glycemic Variability
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms