The Desire PLUS Study - Effects of Glucagon-like-Peptide-1 Analogues on Sexuality: a Prospective Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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".
排除标准
- •Diabetes mellitus, HbA1c ≥ 6,5 %
- •Previous use of GLP-1 analogues during last 2 months.
- •Exogenous testosterone substitution
- •Current illicit drug abuse
- •Pregnancy
结局指标
主要结局
Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning
时间窗: At baseline (before start of treatment, at V1) and after 4-6 months 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.
次要结局
- 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 semen concentration(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in maximum heart rate during spiroergometry(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in the Freiburg questionnaire for physical activity (FQPA)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- 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 4-6 months of treatment (V2))
- Change in extracellular water (%)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in visceral fat (%)(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))
- 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 Testosterone level (nmol/l) (hormone of the reproductive axis)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in Prolactin level (yg/l) (hormone of the reproductive axis)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in semen motility(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in body weight (kg)(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 peak oxygen consumption during spiroergometry to assess physical fitness(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in Estradiol level (pmol/l) (hormone of the reproductive axis)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in Luteinising hormone (LH) level (U/l) (hormone of the reproductive axis)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in body fat mass (%)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in total body water (l)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in intracellular water (%)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in Basal metabolic rate ((kcal/24h)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in Follicle stimulating hormone (LH) level (U/l) (hormone of the reproductive axis)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in sperm fragmentation index (percentage of sperm with fragmented DNA)(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))
- Change in hip/waist ratio(At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2))