Leuprolide acetate for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado Anschutz Medical Campus, Aurora, CO
Obesity+1 More
Leuprolide acetate - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether brown adipose tissue activity is modulated by estrogen.

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Eligible Conditions

  • Obesity
  • Menopause

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Leuprolide acetate will improve 3 primary outcomes and 2 secondary outcomes in patients with Obesity. Measurement will happen over the course of 5-6 hrs..

5-6 hrs
Brown Adipose Tissue Activity - ColdExposure
Brown Adipose Tissue Activity -Warm Exposure
Brown Adipose Tissue Volume
Resting energy expenditure - after cold exposure
5-6 hrs.
Resting energy expenditure - before cold exposure

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Post-menopausal women
1 of 2
Pre-menopausal women
1 of 2
Active Control
Experimental Treatment

This trial requires 72 total participants across 2 different treatment groups

This trial involves 2 different treatments. Leuprolide Acetate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Pre-menopausal women
Drug
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Post-menopausal womenTo determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5-6 hrs
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5-6 hrs for reporting.

Closest Location

University of Colorado Anschutz Medical Campus - Aurora, CO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study volunteers will be healthy women of childbearing age who have regular periods (no missed cycles in the past year; their periods last between 25 and 35 days). show original
and no uterine bleeding for at least 6 months Healthy women who have not had a menstrual period for at least 12 months and have not had uterine bleeding for at least 6 months are eligible to volunteer for this study. show original

Patient Q&A Section

Does obesity run in families?

"In a recent study, findings suggest a common genetic factor may explain why some individuals exhibit an increase in both BMI and waist circumference with age while others do not." - Anonymous Online Contributor

Unverified Answer

How serious can obesity be?

"Obese individuals are more likely to be obese than their lean counterparts. The morbidity and mortality associated with obesity is substantial and poses major health costs as far as the individual, familial and social impact is concerned. Thus, obesity should be considered a public health issue." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of obesity?

"We conclude that obesity is primarily caused by lifestyle factors including genetics. To reduce the obesity epidemic we have to deal with the environmental factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for obesity?

"Obesity is one of the most common chronic illnesses, with prevalence rates at 20 to 60% in the general population. More than half of individuals who were categorized as obese receiving treatment would benefit from a weight loss intervention, and obesity management is a common health intervention. Among those receiving treatment at least half would benefit from more education, while half would benefit from more behavioral counseling. However, given the low rates of achieving or maintaining weight loss goals, further research into the utility of various interventions in obesity management is warranted." - Anonymous Online Contributor

Unverified Answer

What is obesity?

"Obesity is a condition of surplus fat mass that is associated with several health complications. Overweight people in many countries are no longer at risk of mortality from cardiovascular disease; however, morbidity in heart disease and Type 2 diabetes continues to increase." - Anonymous Online Contributor

Unverified Answer

Can obesity be cured?

"Despite the prevalence of obesity, studies on the effect of bariatric surgery to achieve weight loss are rare. Data on weight loss rates and outcomes are available for gastric bypass, adjustable gastric banding, and adjustable gastric banding, but have been few. There is no evidence that weight loss surgery (including bariatric surgery) can achieve meaningful weight loss in excess of 5 kg. A further comparative review is required of all major bariatric surgery operations." - Anonymous Online Contributor

Unverified Answer

What are the signs of obesity?

"Symptoms of obesity include increased appetite, increased food consumption and decreased activity. As time passes, individuals are likely to develop more severe symptoms related to obesity." - Anonymous Online Contributor

Unverified Answer

What causes obesity?

"Approximately one third of young adults in the USA are classified as obese, with this group representing an increased burden from both direct and indirect premature mortality. Childhood obesity is becoming the norm for the young adult population, the rate of prevalence of obesity among those aged 18-29 in New York City increased sharply from 2% to 33% in 2007." - Anonymous Online Contributor

Unverified Answer

How many people get obesity a year in the United States?

"The data suggest a rise in the number of obese adolescents and adults since the years 1991-1996. It is likely that the increase is at least partly attributable to increased tobacco use and consequent weight gain." - Anonymous Online Contributor

Unverified Answer

What is leuprolide acetate?

"A highly specific short-acting LH-RH-agonist is more effective in the treatment of hirsutism than norethisterone to women with PCOS. The higher circulating free and total testosterone concentrations in women compared to men may contribute to the higher rates of hirsutism seen in women. A single intranasal application of the LH-releasing agent leuprolide acetate was effective in reducing hirsutism in women with PCOS." - Anonymous Online Contributor

Unverified Answer

Is leuprolide acetate safe for people?

"Leuprolide acetate appears to be a relatively safe drug when used as described in this study, although there was one case of urogenital toxicity. We believe that further studies in this area are warranted in order to confirm safety and determine whether the use of leuprolide acetate in this population will lead to improved control of blood pressure. Further studies are also needed to elucidate the exact mechanism by which it is safe." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving leuprolide acetate?

"Compared with other long-term treatments for BPH, leuprolide acetate has an earlier start date, shorter duration, and a higher incidence of discontinuation due to side-effects. The long-term advantages of long-acting gonadotropin-releasing injectable therapy should outweigh the risks in patients with severe chronic illness and in whom other therapies are not appropriate. In addition, leuprolide acetate should be considered in all cases of symptomatic nonresponders to oral therapy before considering alternative treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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