Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease

NCT03342742 | Completed Results

• 2 other identifiers: 17-1327R03DK118215
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Polycystic Kidney, Autosomal Dominant

Outcome Measures

Primary Outcomes (5)

• Feasibility to Enroll and Retain Participants

  Numbers of individuals pre-screened

  Through study completion, an expected duration of 18 months

• Feasibility to Enroll Participants

  Numbers of individuals screened

  Through study completion, an expected duration of 18 months

• Feasibility to Retain Participants

  Numbers of individuals enrolled

  Through study completion, an expected duration of 18 months

• Feasibility to Retain Participants

  Numbers of individuals retained

  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

  Baseline, 12 weeks, and 1 year

Secondary Outcomes (18)

• Safety and Tolerability, Measured as Adverse Events

  1 year

• Quality of Life Scores at Baseline

  Baseline

• Quality of Life Scores at 12 Weeks

  12 Weeks

• Quality of Life Scores at 1 Year

  1 Year

• Mood at Baseline

  Baseline

Study Arms (2)

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.

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).

Behavioral: Weight Loss

Interventions

Weight Loss BEHAVIORAL

Weight loss behavioral intervention via one of two strategies.

Daily Caloric Restriction; Intermittent Fasting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Kristen Nowak

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• St 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.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Results Point of Contact

• Title: Kristen Nowak
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Kristen Nowak, Ph.D., MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 17, 2017
• Study Start: June 4, 2018
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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).

Locations

US (1)