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NCT Number: NCT06716125

Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

obese male usually complain subjective tinnitus that may affect their sexual function.

Recruiting

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Key information

Conditions

Obesity Body Weight Ear Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Hearing Disorders Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Tinnitus Tinnitus, Subjective Urogenital Diseases

Age range

35 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

this study will enroll forty obese males with subjective tinnitus (bilateral complaint) and sexual dysfunction (erectile dysfunction) who will be divided to group I and group II with an equal number of males within each group (n =20 for the group). all male in both groups will administer low calorie diet for 12 weeks but Group I will additionally administer supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese person
  • body mass index less than 40 kg/m2 and more than 30 kg/m2
  • males with subjective tinnitus (bilateral presentation from at least 24 weeks).
  • males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

Exclusion criteria

  • cardiac diseased males
  • respiratory diseased males
  • hepatic, musculoskeletal, and hepatic diseased males
  • diabetic males

Treatment and study plan

aerobic treadmill walking plus low calorie diet

Behavioral

this group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking treadmill aerobic training for 45 minutes 3 times per week for 12 weeks).

Low calorie diet

Behavioral

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Primary outcomes

  1. international index of erectile function

    Time frame: it will be assessed after 12 weeks

    Arabic form that contain five question will be used

Secondary outcomes

  1. body mass index

    Time frame: it will be assessed after 12 weeks

    it will be assessed at empty stomach and bladder

  2. waist circumference

    Time frame: it will be assessed after 12 weeks

    it will be assessed at level of umbilicus

  3. visual analogue scale of severity of tinnitus

    Time frame: it will be assessed after 12 weeks

    it will be 10-cm line that will be used to assess tinnitus severity

  4. visual analogue scale of discomfort induced by tinnitus

    Time frame: it will be assessed after 12 weeks

    it will be 10-cm line that will be used to assess discomfort induced by tinnitus

  5. tinnitus handicap inventory

    Time frame: it will be assessed after 12 weeks

    it is a questionnaire that will assess quality of life impacted by tinnitus

  6. triglycerides

    Time frame: it will be measured after 12 weeks

    it will be measured in plasma

  7. high density lipoprotein

    Time frame: it will be measured after 12 weeks

    it will be measured in plasma

  8. atherogenic index

    Time frame: it will be measured after 12 weeks

    it will be assessed as and indicator of atherosclerotic status

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Isamil, Lecturer

CONTACT

[email protected]

0201005154209

ahmed elfahl, Lecturer

CONTACT

[email protected]

0201001891218

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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