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

NCT02620670 | Completed

• 1 other identifier: EAFVG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Physical Activity; Glycemic Variability

Outcome Measures

Primary Outcomes (1)

• Mean amplitude of glucose excusions (MAGE)

  Before and after the physical activity of moderate intensity outpatient daily glucose monitor iPro ™ 2

  6 days

Secondary Outcomes (3)

• Body mass index

  6 days

• Waist circumference

  6 days

• Postprandial glucose

  6 days

Study Arms (2)

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

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

Behavioral: Physical activity of moderate intensity for 3 days

Interventions

Physical activity of moderate intensity for 3 days BEHAVIORAL

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

Individuals with normal weight; Individuals with obesity

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Esperanza Martínez-Abundis, PhD

  Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Esperanza Martínez-Abundis

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: December 3, 2015
• Study Start: April 15, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 27, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-01

Locations

ME (1)