Effects of Glucagon-like-Peptide-1 Analogues on Sexuality (Desire PLUS)

University Hospital Basel

Status: Enrolling

Conditions: Sexual Desire

Study type: Observational

Funder types: Other

Identifiers

NCT05598008

2022-01367 kt22Winzeler;

Details and patient eligibility

About

This study is to investigate the effects of GLP-1 analogues (combined with lifestyle interventions in comparison to lifestyle interventions only) on sexual desire, mood, quality of life, the reproductive axis, retinal vessel diameters, physical fitness (and semen, for men only) in overweight or obese men and women.

Full description

Glucagon-like peptide-1 (GLP-1) analogues are widely used for the treatment of type 2 diabetes mellitus due to its well-known insulinotropic effects as well as for the treatment of obesity due to its satiation-promoting and appetite- suppressant effects. The GLP-1 analogues are approved in patients with obesity (BMI ≥ 30 kg/m2) or who are overweight (BMI ≥ 27 kg/m2) with additional comorbidities, such as prediabetes, diabetes mellitus type 2, arterial hypertension or dyslipidemia. Beside its influence on the reward for palatable food, several studies have shown that GLP-1 analogues modulate the rewarding effects of addictive drugs such as alcohol, nicotine and cocaine. As a further natural reward, sexual desire could be affected by GLP-1 analogues likewise.

This study investigates the influence of GLP-1 analogues on sexuality in a population of overweight and obese participants. A treatment with a GLP-1 analogue combined with lifestyle modifications for weight reduction will be compared to weight reduction with conventional lifestyle modifications only. In the context of the increasing use of GLP-1 analogues, particularly in young people with reproductive desire, laboratory analyzes of the reproductive axis (hormones and sperm cells) will be part of this study to document a possible influence. Mood changes, physical activity and fitness and effects on microvascular endothelial functioning by measuring diameters of retinal vessels will be further investigated.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI ≥ 27 kg/m2

• Willingness to lose weight by lifestyle changes only or by lifestyle changes plus GLP-1 analogue treatment as agreed in a routine clinical appointment

• Active sex life (sex with partner or masturbation ≥2x/month)

• Eugonadism:

  • Men: morning total testosterone ≥12mmol/l or free testosterone ≥ 0.198 nmol/l if< 50 years old and ≥ 0.163 if > 50 years old
  • Women: no primary or secondary amenorrhea (inclusive menopause) *Secondary amenorrhea is defined as "absence of menses for more than three months in women who previously had regular menstrual cycles or six months in women who had irregular menses".

Exclusion criteria

• Diabetes mellitus, HbA1c ≥ 6,5 %
• Previous use of GLP-1 analogues during last 2 months.
• Exogenous testosterone substitution
• Current illicit drug abuse
• Pregnancy

Trial design

78 participants in 2 patient groups

GLP-1 Group

Description:

GLP-1 Group: receiving GLP-1 analogues for weight management in addition to conventional weight management (= lifestyle intervention plus GLP-1 analogues). Conventional weight management is conducted according to clinical guidelines (in both groups) and includes nutritional and exercise counselling, counselling by motivational coaches and/ or psychological support. Participants in the GLP-1 group will inject the medication themselves.

Lifestyle group

Description:

Lifestyle group: using conventional weight management (= lifestyle intervention only). Conventional weight management is conducted according to clinical guidelines (in both groups) and includes nutritional and exercise counselling, counselling by motivational coaches and/ or psychological support.