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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05598008

Collaborator

Swiss National Science Foundation (Other)

Enrollment

Location

17.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to investigate the effects of the GLP-1 analogue Liraglutide (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 in overweight or obese men.

Condition or Disease	Intervention/Treatment	Phase
Sexual Desire

Detailed Description

Glucagon-like peptide-1 (GLP-1) analogs 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 analog Liraglutide (Saxenda®) is 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 analogs 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 analogs likewise.

This study investigates the influence of GLP-1- analogs on sexuality in a population of overweight and obese participants. A treatment with Liraglutide 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-analogs, 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Desire PLUS Study - Effects of Glucagon-like-Peptide-1 Analogues on Sexuality: a Prospective Open-label Study

Actual Study Start Date :

Nov 23, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Liraglutide Group Liraglutide Group: receiving Liraglutide for weight management in addition to conventional weight management (= lifestyle intervention plus liraglutide). 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 Liraglutide group will inject the medication themselves.
Lifestyle group 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.

Arm

Intervention/Treatment

Liraglutide Group

Liraglutide Group: receiving Liraglutide for weight management in addition to conventional weight management (= lifestyle intervention plus liraglutide). 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 Liraglutide group will inject the medication themselves.

Lifestyle group

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.

Outcome Measures

Primary Outcome Measures

Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
The SDI-2 consists of two items addressing frequency of sexual thoughts or activity, rated by a discrete score ranging from 0 to 7 (0 = not at all; 1 = once a month; 2 = once in two weeks; 3 = once a week; 4 = twice a week; 5 = three to four times a week; 6 = once a day; 7 = several times a day), and eight items rating the strengths of different types of sexual desires, rated by a continuous score ranging from 0 to 8 (0 = no desire to 8 = strong desire). The SDI-2 sum score ranges from 0 to 78. A positive score change indicates improvement of sexual desire.

Secondary Outcome Measures

Change in the International Index of Erectile Function (IIEF-5) questionnaire to assess erectile function [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
The IIEF-5 is a 15-item self-evaluation scale; it provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction.
Change in the Patient Health Questionnaire (PHQ) -9 questionnaire to assess mood changes [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
The PHQ-9 tool may reflect patients' accounts of their experiences of depression and to assess severity of and treatment response. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Change in the Patient Health Questionnaire (EQ-5D-5L) questionnaire to assess quality of life [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). The second part of the questionnaire comprises a standard vertical 20-cm VAS that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex.
Change in retinal vessel diameters to assess microvascular endothelial functioning [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in retinal vessel diameters with the Static Retinal Vessel Analyzer (SVA-T, Imedos Systems UG, Jena, Germany). The system consists of a fundus camera (Topcon TRC NW8) and analyzing software (Visualis 3.2, Imedos Systems UG), allowing non-invasive and non-mydriatic assessment of retinal vessel diameters.
Change in Oxytocin Level (IU) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Oxytocin Level (hormone of the reproductive axis) will be measured in the blood.
Change in semen concentration [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in semen concentration
Change in peak oxygen consumption during spiroergometry to assess physical fitness [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in peak oxygen consumption during spiroergometry
Change in maximum heart rate during spiroergometry [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in maximum heart rate during spiroergometry
Change in the Freiburg questionnaire for physical activity (FQPA) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
The questionnaire consists of 12 items and allows a calculation of weighted metabolic equivalent tasks (MET) hours per week. The Physical Activity Questionnaire (FPAQ) is used to measure physical activity. Individuals are considered physically active when they achieved metabolic equivalent tasks (MET) minutes of 600 or more per week.
Change in Testosterone level (nmol/l) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Testosterone level (hormone of the reproductive axis) will be measured in the blood.
Change in Sex hormone-binding globulin (SHBG) level (nmol/l) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Sex hormone-binding globulin (SHBG) level (hormone of the reproductive axis) will be measured in the blood.
Change in Luteinising hormone (LH) level (U/l) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Luteinising hormone (LH) level (hormone of the reproductive axis) will be measured in the blood.
Change in Follicle stimulating hormone (LH) level (U/l) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Follicle stimulating hormone level (hormone of the reproductive axis) will be measured in the blood.
Change in Prolactin level (yg/l) (hormone of the reproductive axis) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Prolactin level (hormone of the reproductive axis) will be measured in the blood.
Change in semen motility [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in semen motility
Change in sperm fragmentation index (percentage of sperm with fragmented DNA) [At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)]
Change in sperm fragmentation index (percentage of sperm with fragmented DNA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI ≥ 27 kg/m2
Willingness to lose weight by lifestyle changes only or by lifestyle changes plus liraglutide treatment as agreed in a routine clinical appointment
Active sex life (sex with partner or masturbation ≥2x/month)
Eugonadism (morning total testosterone ≥12mmol/l)