Polycystic Kidney, Autosomal DominantNCT03342742
Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
A study testing Weight Loss in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 13 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- BMI 25-45 kg/m^2
- Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD-EPI equation
- Access to the internet with video chat capabilities
- No plans for extended travel (>2 weeks) during the 3 month intesive period
- Not currently participating in another interventional study or weight loss program
- Ability to provide informed consent
Who cannot join
- Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
- Current nicotine use or history of use in the past 12 months
- Alcohol or substance abuse (self-report or undergoing treatment)
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
- Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
Show all 18Show fewer
- Pregnancy, lactation, or unwillingness to use adequate birth control
- Cardiovascular disease, peripheral vascular disease, cerebrovascular disease, significant pulmonary or gastrointestinal disease (described below), cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis)
- Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval > 480 msec or other significant conduction defects
- Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease
- Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
- Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants; Study M.D. will be consulted as needed; antibiotics started during the intervention period are not an exclusion); regular use of obesity pharmacotherapeutic agents within the last 6 month
- History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder
- Weight loss >5% in past 3 months for any reason except post-partum weight loss; weight gain >5% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study.
- Untreated hyper- or hyperthyroidism (TSH outside of normal range for laboratory or history of uncontrolled thyroid disorder). History of thyroid disorder or current thyroid disease treated with stable medication regimen for at least 6 months in acceptable.
- Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode.
- History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions.
- Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Trial locations and contacts
1 site in 1 country.
About this study
The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will also compare these two interventions in terms of safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight into a) biological changes and b) changes in kidney growth with each of the two weight loss interventions.
Read the detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Surprisingly, the role of obesity in ADPKD progression is currently unknown. The investigators have novel preliminary data that overweight and obesity are independently associated with substantially faster kidney growth in ADPKD patients. Furthermore, in rodent models of ADPKD, mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function via mechanisms including AMPK-activated kinase pathway activation and suppression of mammalian target of rapamycin/S6 kinase signaling and insulin-like growth factor-1 levels. Collectively, these data suggest that dietary restriction regimens may slow ADPKD progression. Accordingly, the primary aim is to determine the feasibility of delivering a 1 year behavioral weight loss intervention program in 30 overweight/obese adults with ADPKD, based on either daily caloric restriction (DCR) or intermittent fasting (IMF), with a similar (~34%) targeted weekly energy deficit. A key secondary goal is to evaluate safety, acceptability, and tolerability of IMF in ADPKD versus DCR. Last, the third exploratory aim is to a) obtain mechanistic insight into biological pathways that may be altered and b) provide initial insight into any changes in total kidney volume by magnetic resonance imaging with IMF and/or DCR.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Weight Loss
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossBehavioural
Weight loss behavioral intervention via one of two strategies.
| Study group | Role | What they receive |
|---|---|---|
| Daily Caloric Restriction | Experimental | The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements. Receives: Behavioral: Weight Loss |
| Intermittent Fasting | Experimental | Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group). Receives: Behavioral: Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to Enroll and Retain Participants
Numbers of individuals pre-screened
Measured: Through study completion, an expected duration of 18 months
Feasibility to Enroll Participants
Numbers of individuals screened
Measured: Through study completion, an expected duration of 18 months
Feasibility to Retain Participants
Numbers of individuals enrolled
Measured: Through study completion, an expected duration of 18 months
Feasibility to Retain Participants
Numbers of individuals retained
Measured: Through study completion, an expected duration of 18 months
Percent Change From Baseline Body Weight (Weight Loss)
Measurement of body weight pre to post intervention in each group
Measured: Baseline, 12 weeks, and 1 year
Secondary outcomes (18)
Safety and Tolerability, Measured as Adverse Events
Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire
Measured: 1 year
Quality of Life Scores at Baseline
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
Measured: Baseline
Quality of Life Scores at 12 Weeks
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
Measured: 12 Weeks
Quality of Life Scores at 1 Year
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
Measured: 1 Year
Mood at Baseline
Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores for the Vigor scale range from 0 to 32, with higher scores for indicating a better outcome. Possible scores for the fatigue scale range from 0 to 28 with higher scores indicating a worse outcome.
Measured: Baseline
Mood at 12 Weeks
Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.
Measured: 12 Weeks
Mood at 1 Year
Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.
Measured: 1 Year
Change in Energy Intake
Self-reported energy intake
Measured: Baseline, 12 weeks and 1 year
Change in Macronutrient Intake
Self-reported macronutrient intake
Measured: Baseline, 12 weeks and 1 year
Serum Insulin-like Growth Factor-1 Levels at Baseline
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Measured: Baseline
Serum Insulin-like Growth Factor-1 Levels at 12 Weeks
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Measured: 12 Weeks
Serum Insulin-like Growth Factor-1 Levels at 1 Year
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Measured: 1 Year
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Measured: Baseline
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Measured: 12 Weeks
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Measured: 1 Year
Change in PBMC Ratio of pS6K/s6K
Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group.
Measured: Baseline and 1 year
Change in PBMC pAMPK/AMPK Expression
Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group
Measured: Baseline and 1 year
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)
Percent change from baseline in height adjusted total kidney volume by MRI in each group
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start4 Jun 2018
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Nowak, Ph.D., MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342742
- Sponsor's protocol ID
- 17-1327
- Other IDs
- R03DK118215
- Status last verified
- Feb 2022
- First submitted
- 27 Oct 2017
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
PubMed 42789922St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT03342742
- Acronym / sponsor ID
- 17-1327
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will also compare these two interventions in terms of safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight into a) biological changes and b) changes in kidney growth with each of the two weight loss interventions.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Surprisingly, the role of obesity in ADPKD progression is currently unknown. The investigators have novel preliminary data that overweight and obesity are independently associated with substantially faster kidney growth in ADPKD patients. Furthermore, in rodent models of ADPKD, mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function via mechanisms including AMPK-activated kinase pathway activation and suppression of mammalian target of rapamycin/S6 kinase signaling and insulin-like growth factor-1 levels. Collectively, these data suggest that dietary restriction regimens may slow ADPKD progression. Accordingly, the primary aim is to determine the feasibility of delivering a 1 year behavioral weight loss intervention program in 30 overweight/obese adults with ADPKD, based on either daily caloric restriction (DCR) or intermittent fasting (IMF), with a similar (~34%) targeted weekly energy deficit. A key secondary goal is to evaluate safety, acceptability, and tolerability of IMF in ADPKD versus DCR. Last, the third exploratory aim is to a) obtain mechanistic insight into biological pathways that may be altered and b) provide initial insight into any changes in total kidney volume by magnetic resonance imaging with IMF and/or DCR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Caloric Restriction | Experimental | Behavioral: Weight LossThe daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements. |
| Intermittent Fasting | Experimental | Behavioral: Weight LossParticipants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-65 years
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- BMI 25-45 kg/m^2
- Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD-EPI equation
- Access to the internet with video chat capabilities
Key exclusion criteria (18 listed)
- Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
- Current nicotine use or history of use in the past 12 months
- Alcohol or substance abuse (self-report or undergoing treatment)
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight LossWeight loss behavioral intervention via one of two strategies. | Behavioural | Daily Caloric Restriction, Intermittent Fasting |
Primary outcome
Feasibility to Enroll and Retain Participants
Time frame: Through study completion, an expected duration of 18 months
Numbers of individuals pre-screened
Feasibility to Enroll Participants
Time frame: Through study completion, an expected duration of 18 months
Numbers of individuals screened
Feasibility to Retain Participants
Time frame: Through study completion, an expected duration of 18 months
Numbers of individuals enrolled
Feasibility to Retain Participants
Time frame: Through study completion, an expected duration of 18 months
Numbers of individuals retained
Percent Change From Baseline Body Weight (Weight Loss)
Time frame: Baseline, 12 weeks, and 1 year
Measurement of body weight pre to post intervention in each group
18 secondary outcomes
Safety and Tolerability, Measured as Adverse Events
Time frame: 1 year
Quality of Life Scores at Baseline
Time frame: Baseline
Quality of Life Scores at 12 Weeks
Time frame: 12 Weeks
Quality of Life Scores at 1 Year
Time frame: 1 Year
Mood at Baseline
Time frame: Baseline
Mood at 12 Weeks
Time frame: 12 Weeks
Mood at 1 Year
Time frame: 1 Year
Change in Energy Intake
Time frame: Baseline, 12 weeks and 1 year
Change in Macronutrient Intake
Time frame: Baseline, 12 weeks and 1 year
Serum Insulin-like Growth Factor-1 Levels at Baseline
Time frame: Baseline
Serum Insulin-like Growth Factor-1 Levels at 12 Weeks
Time frame: 12 Weeks
Serum Insulin-like Growth Factor-1 Levels at 1 Year
Time frame: 1 Year
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline
Time frame: Baseline
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks
Time frame: 12 Weeks
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year
Time frame: 1 Year
Change in PBMC Ratio of pS6K/s6K
Time frame: Baseline and 1 year
Change in PBMC pAMPK/AMPK Expression
Time frame: Baseline and 1 year
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42789922Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Nowak, Ph.D., MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to Enroll and Retain Participants (time frame: Through study completion, an expected duration of 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.