Amiloride Pill for Overweight

1
Effectiveness
2
Safety
University of Missouri Hospital and Clinics, Columbia, MO
Overweight+2 More
Amiloride Pill - Drug
Eligibility
18+
All Sexes
Eligible conditions
Overweight

Study Summary

This study is evaluating whether a drug which helps the body remove extra salt may help improve blood pressure and blood vessel function in obese individuals.

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Eligible Conditions

  • Overweight
  • Insulin Resistance
  • Overweight and Obesity

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Amiloride Pill will improve 1 primary outcome and 2 secondary outcomes in patients with Overweight. Measurement will happen over the course of Baseline, 3 months (interim) and 6 months (final).

Month 6
Brachial artery flow mediated dilation (FMD)
Carotid femoral PWV
Popliteal artery flow mediated dilation (FMD)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo
Amiloride
Placebo group

This trial requires 157 total participants across 2 different treatment groups

This trial involves 2 different treatments. Amiloride Pill is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Amiloride
Drug
6 months of amiloride (max dose 5 mg) treatment
Placebo
Drug
6 months of daily placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months (interim) and 6 months (final)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 3 months (interim) and 6 months (final) for reporting.

Who is running the study

Principal Investigator
C. M.
Prof. Camila Manrique, Associate Professor, Endocrinology
University of Missouri-Columbia

Closest Location

University of Missouri Hospital and Clinics - Columbia, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
30 to 70 years of age at randomization
Body mass index (BMI) 25.1-50 kg/m2 or waist circumference > 88 cm (> 35 in) in women and >102 cm (>40 in) in men. 3, 4
One other characteristic of metabolic syndrome (elevated triglycerides ≥150 mg/dl; HDL cholesterol <40 mg/dl in men and <50 mg/dl in women; blood pressure ≥130/85 mm Hg or treatment for hypertension; impaired fasting glucose (≥100 mg/dl)) or fasting insulin level >10 mU/L (correlates with insulin resistance).

Patient Q&A Section

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

Have there been any new discoveries for treating overweight?

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The treatments that have been developed so far are not applicable to the majority of patients but rather to small groups of people. To date, there are five drugs in the market which may be beneficial to treat and prevent overweight.

Unverified Answer

Does overweight run in families?

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Significant heterogeneity exists among the current body-mass indexes of parents and children in this large, world-wide twin population. Because of this heterogeneity, it becomes difficult to draw conclusions about the heritability of overweight, due to differences in the relationship of parents and children of any given set of siblings.

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What are common treatments for overweight?

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The treatment of overweight and obese persons is highly complex and not understood by many physicians; most overweight people will succeed in reaching a target body weight with the most conservative lifestyle recommendations and little or no diet.

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What causes overweight?

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The excess weight of many adolescents is associated with high levels of fatness, abdominal obesity and impaired physiological function, which can be partly explained by low levels of physical activity. It may be prudent to promote physical activity to the extent possible, with the potential to protect overweight adolescents from high levels of body fatness and poor physiological function.

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What is overweight?

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Overweight is a problem for a significant number of children and is increasing in the USA. It is important to understand the factors that contribute to excess body weight gain, including family and community factors (e.g., social environment) and individual factors (e.g., genetics, age, gender).

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Can overweight be cured?

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Even though the data suggests improvements after an initial phase of weight control, the weight of these patients did not return to their previous levels after 12months.

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

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Over time, the proportion of US adults who were overweight in 2002 declined from 31.3% to 27.7% in 2006. There were more men than women with a BMI greater than or equal to obesity in 2005 than in 2002 or 2006, but the proportion of adults with body mass indexes of greater than or equal to obesity has remained stable over time.

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What are the signs of overweight?

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Signs of overweight and obesity may vary widely from person to person. Overweight is often overlooked because the signs are often subtle and non-specific. In some instances, weight loss is the most visible symptom of diabetes mellitus. If this is the case, the diagnosis will be missed, especially if weight loss in this condition is precipitated by obesity-related diseases or conditions that are either related or associated with obesity. Thus, early and aggressive diagnosis of diabetes, hypertension and obesity is essential so that the diseases may be treated promptly and adequately.

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How serious can overweight be?

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Obesity can lead to many serious health problems which can only be alleviated by changes in lifestyle behaviours. Some of the major health problems associated with obesity include diabetes, cardiovascular disease, osteoarthritis, sleep apnea, hypertension and many others. The prevalence of overweight was 25.2% in an Australian sample in 2009. While obesity is associated with high morbidity and mortality, there is a lack of awareness in the community. Awareness campaigns highlight the physical and mental health issues associated with overweight.

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How does amiloride pill work?

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Oral amiloride treatment is effective in improving both glycemic control and the risk of hypoglycemia in severely obese nondiabetic patients with type 2 diabetes in whom diet treatment alone has been ineffective.

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What are the latest developments in amiloride pill for therapeutic use?

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Amiloride pills have more and more indications. As of 2015, the latest one being in the treatment of heart failure and chronic kidney disease. As mentioned in the article, if a patient does not tolerate the contraindications, or does not have it available in his region (e.g. as a foreign drug) then he can definitely get it from abroad.

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Does amiloride pill improve quality of life for those with overweight?

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Recent findings of this study suggest that amiloride may improve quality of life in some people who are overweight, especially those who are mildly obese. We recommend that people with chronic illnesses should undertake trials of amiloride during an exacerbation in order to prevent worsening of their condition. This is feasible with amiloride because the drug also lowers blood pressure, and is thus effective in treating patients with hypertension. Therefore, in some cases amiloride can be used to prevent exacerbations and even a potential deterioration in the condition.

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