Clinical trial NCT01353001: Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
Official title: The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Keywords: Intervention Studies
Magnetic Resonance Imaging
C-Reactive Protein
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the effect of weight loss and exercise on cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III obese women during a 12 week training intervention.

Detailed description: To date, research investigating obesity, inflammation, and cardiovascular disease has utilized lifestyle interventions focused on weight loss and exercise among groups with BMI classifications of normal, overweight and mildly obese. A limitation of recent investigations is the failure to utilize participants who are significantly overweight. Those whose BMI classification extends to Class II and Class III obesity (BMI \> 35.0, and BMI \> 40.0) have not yet been studied at length, yet these individuals have been shown to be able to substantially improve their cardiovascular risk profiles without attaining a BMI below 25. Inactivity has been linked to increased adiposity and a trend toward higher levels of cardiovascular disease risk. It is necessary to study the relationships between weight loss and weight loss with added physical activity among Class II and Class III obese participants in order to gain a more thorough knowledge of the effects of BMI on circulating markers of inflammation and the cardiac structural and functional changes associated with weight loss among this population. A second limitation of the current research is the use of strictly progressive resistance training protocols. The protocols used have increased constantly in intensity or volume, if not both. Constant increases in intensity tend to lead to overtraining among participants, highlighting a need for more variation of intensity and volume in the training protocol in order to avoid stagnation and overtraining. Finally, no research has studied the specific impact of diet and resistance training on either CRP or cardiovascular adaptations.

Eligibility criteria: Inclusion Criteria:

* Female
* 30-55 years of age
* BMI = 35.0-44.9 kg/m2

Exclusion Criteria:

* Currently pregnant, pregnant in the past 6 months, or planning on becoming pregnant in the next 6 months.
* Regularly exercising for greater than 60 minutes per week.
* Taking prescription or over-the-counter medications that affect body weight, metabolism, blood pressure, or heart rate, such as psychotropic medications (e.g. zoloft, prozac, paxil, xanax) and medications that have metabolic effects (e.g. synthroid, wellbutrin, metformin).
* Having physical limitations that hinder or prevent exercise.
* Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
* Having a resting systolic blood pressure of \> 150mmHg of diastolic blood pressure of \> 100mmHg or currently taking any medications that affect blood pressure or heart rate (i.e. beta blockers).
* Currently enrolled in an exercise or weight control study or participating in an exercise or weight control study in the past 6 months.
* Have lost and not regained \> 5% body weight in the past 6 months.
* Currently being treated for any psychological problems or taking any psychotropic medications.
* Abnormal kidney functions, as per current institutional standard for gadolinium administration.
* Known allergy to IV gadolinium, or the discovery of an allergic reaction to IV gadolinium at baseline.

Primary outcomes:
measure: Cardiovascular Disease Risk Factors
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: Weight Loss
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven D Verba, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Blake D Justice, MS
role: STUDY_DIRECTOR
References: