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

May 10, 2023 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Endocrinology, Diabetes and Metabolism
        • Contact:
        • Principal Investigator:
          • Bettina Winzeler, Dr. med.
        • Sub-Investigator:
          • Sophia Lengsfeld, Dr. med.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population will consist of overweight men (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.

Description

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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the International Index of Erectile Function (IIEF-5) questionnaire to assess erectile function
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in the Patient Health Questionnaire (PHQ) -9 questionnaire to assess mood changes
Time Frame: 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).
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in the Patient Health Questionnaire (EQ-5D-5L) questionnaire to assess quality of life
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in retinal vessel diameters to assess microvascular endothelial functioning
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Oxytocin Level (IU) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in semen concentration
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in semen concentration
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in peak oxygen consumption during spiroergometry to assess physical fitness
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in peak oxygen consumption during spiroergometry
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in maximum heart rate during spiroergometry
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in maximum heart rate during spiroergometry
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in the Freiburg questionnaire for physical activity (FQPA)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Testosterone level (nmol/l) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Sex hormone-binding globulin (SHBG) level (nmol/l) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Luteinising hormone (LH) level (U/l) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Follicle stimulating hormone (LH) level (U/l) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Prolactin level (yg/l) (hormone of the reproductive axis)
Time Frame: 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.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in semen motility
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in semen motility
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)
Time Frame: 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)
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Estradiol level (pmol/l) (hormone of the reproductive axis)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Estradiol level (hormone of the reproductive axis) will be measured in the blood.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in body weight (kg)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Body weight is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in body fat mass (%)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Body fat mass is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in total body water (l)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Total body water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in extracellular water (%)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Extracellular water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in intracellular water (%)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Intracellular water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in hip/waist ratio
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Hip/waist ratio is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in Basal metabolic rate ((kcal/24h)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Basal metabolic rate is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Change in visceral fat (%)
Time Frame: At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)
Visceral fat is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.
At baseline (before start of treatment, at V1) and after 16 weeks of treatment (V2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Bettina Winzeler, Dr. med., Endocrinology, Diabetes and Metabolism, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-01367; kt22Winzeler

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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