An interventional study of Dietary in Polycystic Kidney, Autosomal Dominant, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-10.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other
Among 12 studies in Polycystic Kidney, Autosomal Dominant by University of Colorado, Denver — 1 open to participants now, 5 under way, none of them phase 3. Polycystic Kidney, Autosomal Dominant · University of Colorado, Denver.
Among the 12 studies in Polycystic Kidney, Autosomal Dominant by University of Colorado, Denver, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2021, is one of 4 with no phase, and was the 8th registered.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
Browse Polycystic Kidney, Autosomal Dominant studies →1 of the 12 studies in Polycystic Kidney, Autosomal Dominant by University of Colorado, Denver is open now, in 1 country. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
By country, each count listing its studies:
Of the 30 Polycystic Kidney, Autosomal Dominant studies recruiting now, 8 (27%) set no upper age limit and 19 (63%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2021.
This study's enrollment of 29 is below the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Median enrollment 61 across the 11 interventional studies, 22 across the 1 observational. Of the 7 that completed or were terminated, 5 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
2 of the studies in Polycystic Kidney, Autosomal Dominant by University of Colorado, Denver that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04907799University of Colorado, DenverDaily Caloric Restriction in ADPKD | 2027-06-30 |
| NCT06496542University of Colorado, DenverRenal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD | 2027-08-01 |
Among the 12 studies in Polycystic Kidney, Autosomal Dominant by University of Colorado, Denver, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The proposed research will determine the feasibility of a time restricted feeding intervention,a fasting regimen that restricts eating to a feeding window (8 hrs/day) for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will provide valuable information on the intervention in terms of safety, adherence, acceptability, and tolerability. Last, this pilot trial will provide initial insight into biological changes including abdominal adiposity, changes in kidney growth and function, and markers of biological pathways related to the intervention.
Mounting evidence suggests that a metabolic defect exists in autosomal dominant polycystic kidney disease (ADPKD), which likely contributes to cystic epithelial proliferation and subsequent cyst growth. There are notable overlapping features and pathways among metabolism, obesity, and/or ADPKD. The investigators recently reported that in the Halt Progression of Polycystic Kidney Disease (HALT-PKD) Study A that overweight and obesity are strong independent predictors of more rapid kidney growth. Moving beyond body mass index, the investigators have novel preliminary data using magnetic resonance images (MRIs) from a small number of participants from HALT-PKD Study A that abdominal adiposity is an independent predictor of kidney growth and kidney function decline. Adipocytes do not simply act as a fat reservoir but are active endocrine organs that promote release of pro-inflammatory cytokines and produce adipokines. Numerous signaling pathways promoted by adipocytes are also implicated in cystogenesis. Periods of fasting may counter adiposity-mediated signaling pathways and slow ADPKD progression. Mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function in rodent models of ADPKD, which are characterized by metabolic reprogramming favoring enhanced aerobic glycolysis. Notably, fasting promotes a shift from carbohydrate to fat metabolism, which could suppress cyst growth. The investigators are currently conducting an ongoing behavioral weight loss pilot trial (based on either daily caloric restriction or intermittent fasting) in adults with ADPKD who are overweight/obese. As an alternative to these approaches, time-restricted feeding (TRF) is a novel fasting regimen that restricts eating to a feeding window (typically 8-12 hrs/day). As isocaloric TRF reduces disease progression in a rodent model of ADPKD, including kidney: body weight and mammalian target of rapamycin (mTOR) activity, it may be an alternative and easier to adhere to dietary strategy to slow ADPKD progression. Specific Aim: Determine the feasibility of TRF without energy intake restriction in adults with ADPKD and overweight/obesity. The study will determine adherence to TRF by assessing the percent of participants achieving the goal of eating within an 8-hour TRF window, measured objectively with a photographic food record and verified with continuous glucose monitoring data. The study will also further assess the safety, acceptability, and tolerability of TRF by evaluation of safety labs, adverse events, and quality of life measures, as well as changes in abdominal adiposity and total kidney volume (TKV) by magnetic resonance imaging (MRI), and markers of biological pathways (AMP-activated protein kinase [AMPK], mTOR, insulin-like growth factor 1 [IGF1]).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Instructed to eat within an 8-hr window, beginning within 3 hrs of waking. In addition, provide current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.
Behavioral: Dietary
Curriculum for the healthy eating control group will emphasize current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.
Behavioral: Dietary
Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted
Adherence
Percent adherence to the 8-hr TRF window (during the 7 day recordng period)
Time frame: 1 year
Feasibility to enroll participants
Numbers of individuals pre-screened and enrolled
Time frame: Through study enrollment, an expected duration of 12 months
Feasibility to retain participants
Numbers of individuals retained
Time frame: Through study completion, an expected duration of 24 months
Safety and tolerability, measured as adverse events
Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
Time frame: Through study completion, an expected duration of 24 months
Change in Body Weight
Body weight will be measured at baseline and monthly, using BodyTrace scales for remote, secure transmission of data.
Time frame: 1 year
Change in Abdominal adiposity
Abdominal adiposity will be quantified using MRI
Time frame: 1 year
Change in Body Composition
Body composition measured via dual-energy X-ray absorptiometry (DEXA)
Time frame: 1 year
Change in insulin-like growth factor binding protein-1 levels
Fasting serum insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Time frame: 1 year
Change in serum insulin-like growth factor-1 levels
Fasting serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Time frame: 1 year
Change in peripheral blood mononuclear cell (PBMC) AMPK expression
Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
Time frame: 1 year
Change in PBMC S6K expression
Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
Time frame: 1 year
Change in β-hydroxybutyrate levels
Serum β-hydroxybutyrate levels in each group
Time frame: 1 year
Change in total kidney volume by magnetic resonance imaging (MRI)
Change in total kidney volume by MRI in each group
Time frame: 1 year
Change in quality of life
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score
Time frame: 1 year
Change in mood
Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
Time frame: 1 year
Change in pain
Modified version of the Wisconsin Brief Pain Survey
Time frame: 1 year
Change in resting energy expenditure
Standard indirect calorimetry
Time frame: 1 year
Change in energy intake
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/continuous glucose monitoring collection period to evaluate self-reported energy intake
Time frame: 1 year
Change in macronutrient intake
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/CGM collection period to evaluate self-reported energy intake
Time frame: 1 year
Change in self-reported physical activity
Self-reported physical activity will be quantified using the Stanford Physical Activity Questionnaire
Time frame: 1 year
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Mar 2023, 25 months.
Of 22 interventional studies with no phase under Polycystic Kidney, Autosomal Dominant, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Polycystic Kidney, Autosomal Dominant →
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