Insulin Resistance Clinical Trial
— TimeMAPOfficial title:
The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice
NCT number | NCT05126199 |
Other study ID # | TimeMAP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2021 |
Est. completion date | January 31, 2023 |
Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | Inclusion Criteria: - Adult women of reproductive age with confirmed diagnosis of PCOS (Rotterdam Criteria, including at least 2 of 3 characteristics: oligomenorrhea, clinical and/or biochemical hyperandrogenism and ultrasound criteria) - No BMI restriction - Able and willing to provide explicit, informed consent Exclusion Criteria: - Type 1 diabetes, medication-controlled type 2 diabetes - Pregnancy - Currently participating in weight loss programme, or reported weight change in last 3 months (>5% of current body weight) - Documented history of eating disorder - Ovulation medication, such as clomiphene citrate - Weight loss medication affecting weight or appetite in last 6 months, including weight loss medications, antipsychotic drugs or other medications as determine by the physician (eg. Semaglutide, liraglutide, orlistat, amphetamines, Qsymia (phentermine-topiramate), bupropion-naltrexone (Contrave)) - Known liver, renal or thyroid dysfunction (not including non-alcoholic fatty liver disease with hypothyroidism on treatment or subclinical hypothyroidism seen in a large proportion of patients with PCOS) - Unable to participate in follow-up for at least 24 weeks - Unable or unwilling to provide explicit, informed consent |
Country | Name | City | State |
---|---|---|---|
Ireland | Robert Graves Institute of Endocrinology, Tallaght University Hospital | Dublin | Leinster |
Lead Sponsor | Collaborator |
---|---|
Ruairí Floyd | Tallaght University Hospital |
Ireland,
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Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drop-out rate | Assessing intervention feasibility | 6 weeks | |
Primary | Drop-out rate | Assessing intervention feasibility | 12 weeks | |
Primary | Adverse outcomes as assessed by CTCAE v4.0 | Assessing intervention feasibility | 6 weeks | |
Primary | Adverse outcomes as assessed by CTCAE v4.0 | Assessing intervention feasibility | 12 weeks | |
Primary | Change in serum insulin | Measured with serum insulin levels to assess effects | 6 weeks | |
Primary | Change in serum insulin | Measured with serum insulin levels to assess effects | 12 weeks | |
Primary | Change in food diaries | Assessment of change of eating behaviours | 6 weeks | |
Primary | Change in food diaries | Assessment of change of eating behaviours | 12 weeks | |
Secondary | Change in insulin resistance | Assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and other ratio calculations measuring insulin resistance | 6 weeks | |
Secondary | Change in insulin resistance | Assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and other ratio calculations measuring insulin resistance | 12 weeks | |
Secondary | Change in testosterone levels | Assessed by plasma testosterone | 6 weeks | |
Secondary | Change in testosterone levels | Assessed by plasma testosterone | 12 weeks | |
Secondary | Change in free testosterone levels | Assessed by plasma free testosterone | 6 weeks | |
Secondary | Change in free testosterone levels | Assessed by plasma free testosterone | 12 weeks | |
Secondary | Change in dehydroepiandrosterone sulfate (DHEA-S) levels | Assessed by plasma dehydroepiandrosterone sulfate (DHEA-S) | 6 weeks | |
Secondary | Change in dehydroepiandrosterone sulfate (DHEA-S) levels | Assessed by plasma dehydroepiandrosterone sulfate (DHEA-S) | 12 weeks | |
Secondary | Change in androstenedione levels | Assessed by plasma androstenedione | 6 weeks | |
Secondary | Change in androstenedione levels | Assessed by plasma androstenedione | 12 weeks | |
Secondary | Change in sex hormone binding globulin (SHBG) levels | Assessed by plasma sex hormone binding globulin (SHBG) | 6 weeks | |
Secondary | Change in sex hormone binding globulin (SHBG) levels | Assessed by plasma sex hormone binding globulin (SHBG)) | 12 weeks | |
Secondary | Change in 17-Hydroxyprogesterone (17-OHP) levels | Assessed by 17-Hydroxyprogesterone (17-OHP) | 6 weeks | |
Secondary | Change in 17-Hydroxyprogesterone (17-OHP) levels | Assessed by 17-Hydroxyprogesterone (17-OHP) | 12 weeks | |
Secondary | Change in appetite | Measured by a validated 10-point visual analogue scale on a scale of 1-10, 1 being not hungry at all and 10 being very hungry | 6 weeks | |
Secondary | Change in appetite | Measured by a validated 10-point visual analogue scale on a scale of 1-10, 1 being not hungry at all and 10 being very hungry | 12 weeks | |
Secondary | Change in markers of satiety | Assess by plasma GLP-1 | 6 weeks | |
Secondary | Change in markers of satiety | Assess by plasma GLP-1 | 12 weeks | |
Secondary | Change in markers of satiety | Assess by plasma PYY | 6 weeks | |
Secondary | Change in markers of satiety | Assess by plasma PYY | 12 weeks | |
Secondary | Change in markers of satiety | Assess by plasma oxyntomodulin | 6 weeks | |
Secondary | Change in markers of satiety | Assess by plasma oxyntomodulin | 12 weeks | |
Secondary | Change in markers of hunger | Assess by plasma ghrelin | 6 weeks | |
Secondary | Change in markers of hunger | Assess by plasma ghrelin | 12 weeks | |
Secondary | Change in fasting glucose | Assessed in serum glucose measurements | 6 weeks | |
Secondary | Change in fasting glucose | Assessed in serum glucose measurements | 12 weeks | |
Secondary | Change in HbA1c | Assessed in serum HbA1c measurements | 6 weeks | |
Secondary | Change in HbA1c | Assessed in serum HbA1c measurements | 12 weeks | |
Secondary | Change in lipids | Assessed by Lipid profile | 6 weeks | |
Secondary | Change in lipids | Assessed by Lipid profile | 12 weeks | |
Secondary | Change in lipids | Assessed by Lipoprotein lipid A levels | 6 weeks | |
Secondary | Change in lipids | Assessed by Lipoprotein lipid A levels | 12 weeks | |
Secondary | Change in lipids | Assessed by Apolipoprotein A1 levels | 6 weeks | |
Secondary | Change in lipids | Assessed by Apolipoprotein A1 levels | 12 weeks | |
Secondary | Change in lipids | Assessed by Apolipoprotein B levels | 6 weeks | |
Secondary | Change in lipids | Assessed by Apolipoprotein B levels | 12 weeks | |
Secondary | Change in body weight | Body weight (kg) | 6 weeks | |
Secondary | Change in body weight | Body weight (kg) | 12 weeks | |
Secondary | Change in body mass index | BMI (kg/m2) | 6 weeks | |
Secondary | Change in body mass index | BMI (kg/m2) | 12 weeks | |
Secondary | Change in anthropometric measurements (waist circumference) | Waist circumference (cm) | 6 weeks | |
Secondary | Change in anthropometric measurements (waist circumference) | Waist circumference (cm) | 12 weeks | |
Secondary | Change in anthropometric measurements (waist-hip ratio) | Waist-hip ratio | 6 weeks | |
Secondary | Change in anthropometric measurements (waist-hip ratio) | Waist-hip ratio | 12 weeks | |
Secondary | Change in dietary intake | Assessed using interval dietary assessments with Nutritics 'app' | 6 weeks | |
Secondary | Change in dietary intake | Assessed using interval dietary assessments with Nutritics 'app' | 12 weeks |
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