Effects of Glucagon-like-Peptide-1 Analogues on Sexuality

NCT05598008 | Completed

• 1 other identifier: 2022-01367; kt22Winzeler
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexual Desire

Keywords

Glucagon-like-Peptide-1 (GLP-1); Glucagon-like peptide-1 (GLP-1) analogues; obesity; sexuality; Liraglutide (Saxenda®); obese men; reproductive axis; microvascular endothelial function; retinal vessels; physical activity; physical fitness; mood; sperm cells

Outcome Measures

Primary Outcomes (1)

• Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning

  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.

  At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

Secondary Outcomes (25)

• Change in the International Index of Erectile Function (IIEF-5) for men or Female Sexual Function Index (FSFI) for women questionnaire to assess sexual health and erectile function

  At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

• Change in the Patient Health Questionnaire (PHQ) -9 questionnaire to assess mood changes

  At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

• 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 4-6 months of treatment (V2)

• Change in retinal vessel diameters to assess microvascular endothelial functioning

  At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

• Change in Oxytocin Level (IU) (hormone of the reproductive axis)

  At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

Study Arms (2)

GLP-1 Group

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

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of overweight men and women (BMI ≥ 27 kg/m2), which are seen at the obesity clinic of the University Hospital Basel and who wish to lose weight by lifestyle changes and optionally in combination with liraglutide treatment.

You may qualify if:

• 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".

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

If the participant has agreed on further use of biological material blood samples will be stored for an indefinite period of time at - 80°C in a thermo-controlled ultra-deep freezer for eventual future research aims (Biobank department of Endocrinology).

MeSH Terms

Conditions

Obesity; Sexuality; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Bettina Winzeler, Dr. med.

  Endocrinology, Diabetes and Metabolism, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 28, 2022
• Study Start: November 25, 2022
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CH (1)