Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lund University | OTHER |
| Danone Global Research & Innovation Center | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).
High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. The main physiological role of vasopressin is to maintain constant plasma osmolality. Previous studies in rats and a Mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.
The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. Furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water intervention | Experimental | The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water | Dietary Supplement | Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma copeptin concentration (pmol/L) | Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour urine osmolality (mosm/kg H2O) | Change of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake. | 6 weeks |
| 24 hour urine volume (L/24h) | Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olle Melander, M.D., Prof | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KFE, Skåne University Hospital in Malmö | Malmö | 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34966186 | Derived | Enhorning S, Vanhaecke T, Dolci A, Perrier ET, Melander O. Investigation of possible underlying mechanisms behind water-induced glucose reduction in adults with high copeptin. Sci Rep. 2021 Dec 29;11(1):24481. doi: 10.1038/s41598-021-04224-5. | |
| 30566641 | Derived | Enhorning S, Brunkwall L, Tasevska I, Ericson U, Persson Tholin J, Persson M, Lemetais G, Vanhaecke T, Dolci A, Perrier ET, Melander O. Water Supplementation Reduces Copeptin and Plasma Glucose in Adults With High Copeptin: The H2O Metabolism Pilot Study. J Clin Endocrinol Metab. 2019 Jun 1;104(6):1917-1925. doi: 10.1210/jc.2018-02195. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2018 | Jun 20, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
Not provided
Not provided
All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
Not provided
Not provided
Not provided
Not provided
| 6 weeks |
| Drinking water (L/day) | Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake. | 6 weeks |
| Total water (L/day) | Change of total water intake between baseline and after 6 weeks of increased water intake. | 6 weeks |
| Fasting plasma glucose concentration (mmol/L) | Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake. | 6 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |