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N/A N=28 Randomized Double-blind Other

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

Polycystic Kidney, Autosomal Dominant

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Feasibility to Enroll and Retain Participants — 122 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Weight Loss (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Colorado, Denver
Primary completion
Oct 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Feasibility to Enroll and Retain Participants
122
PRIMARY
Feasibility to Enroll Participants
29
PRIMARY
Feasibility to Retain Participants
13; 11
PRIMARY
Feasibility to Retain Participants
13; 11
PRIMARY
Percent Change From Baseline Body Weight (Weight Loss)
-7.1; -5.5; -9.1; -4.9
SECONDARY
Safety and Tolerability, Measured as Adverse Events
10; 13
SECONDARY
Quality of Life Scores at Baseline
77; 83; 82; 78
SECONDARY
Quality of Life Scores at 12 Weeks
81; 84; 80; 91
SECONDARY
Quality of Life Scores at 1 Year
80; 91; 81; 76
SECONDARY
Mood at Baseline
8.3; 7.6; 5.2; 6.4
SECONDARY
Mood at 12 Weeks
7.5; 7.3; 7.7; 6.5
SECONDARY
Mood at 1 Year
8.2; 7.9; 5.2; 6.7
SECONDARY
Change in Energy Intake
SECONDARY
Change in Macronutrient Intake
SECONDARY
Serum Insulin-like Growth Factor-1 Levels at Baseline
104; 93
SECONDARY
Serum Insulin-like Growth Factor-1 Levels at 12 Weeks
127; 96
SECONDARY
Serum Insulin-like Growth Factor-1 Levels at 1 Year
103; 101
SECONDARY
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline
9.4; 7.5
SECONDARY
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks
11.1; 8.7
SECONDARY
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year
10.0; 7.9
SECONDARY
Change in PBMC Ratio of pS6K/s6K
0.89; 1.43; 0.42; -0.27
SECONDARY
Change in PBMC pAMPK/AMPK Expression
0.49; .76; 0.12; -0.25
SECONDARY
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)
1.54; 1.70

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03342742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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