Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2009-06-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Atkins group
Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to \<20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the 6 months of the study. Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.
Atkins Diet
Patients are given an outline of the Atkins diet and are asked to follow it for 6 months
Control group
Subjects assigned to the control group will be asked to make no changes in their dietary habits. At the completion of the study subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.
No interventions assigned to this group
Interventions
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Atkins Diet
Patients are given an outline of the Atkins diet and are asked to follow it for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
3. Overweight or obese (body mass index ≥ 25 kg/m2)
Exclusion Criteria
2. Myocardial infarction within 6 months
3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
4. Patient consuming a low-carbohydrate diet
5. Medical conditions or co-morbidities that preclude participation in the protocol
6. Vegetarians
18 Years
MALE
No
Sponsors
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VA Greater Los Angeles Healthcare System
FED
Durham VA Medical Center
FED
University of California, Los Angeles
OTHER
Carolina Urologic Research Center
OTHER
First Urology
UNKNOWN
Duke University
OTHER
Responsible Party
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Principal Investigators
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Stephen J Freedland, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Greater Los Angeles VA Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. doi: 10.1200/JCO.2006.10.1949. Epub 2007 Apr 2.
Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. doi: 10.1056/NEJM199707313370502.
Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.
Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497.
Tsai HK, D'Amico AV, Sadetsky N, Chen MH, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007 Oct 17;99(20):1516-24. doi: 10.1093/jnci/djm168. Epub 2007 Oct 9.
D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289.
Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500. doi: 10.1002/cncr.22933.
Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.
Freedland SJ, Mavropoulos J, Wang A, Darshan M, Demark-Wahnefried W, Aronson WJ, Cohen P, Hwang D, Peterson B, Fields T, Pizzo SV, Isaacs WB. Carbohydrate restriction, prostate cancer growth, and the insulin-like growth factor axis. Prostate. 2008 Jan 1;68(1):11-9. doi: 10.1002/pros.20683.
Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. doi: 10.7326/0003-4819-140-10-200405180-00006.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Barry MJ, Delorenzo MA, Walker-Corkery ES, Lucas FL, Wennberg DC. The rising prevalence of androgen deprivation among older American men since the advent of prostate-specific antigen testing: a population-based cohort study. BJU Int. 2006 Nov;98(5):973-8. doi: 10.1111/j.1464-410X.2006.06416.x. Epub 2006 Jul 28.
Freedland SJ, Howard LE, Ngo A, Ramirez-Torres A, Csizmadi I, Cheng S, Mack A, Lin PH. Low Carbohydrate Diets and Estimated Cardiovascular and Metabolic Syndrome Risk in Prostate Cancer. J Urol. 2021 Dec;206(6):1411-1419. doi: 10.1097/JU.0000000000002112. Epub 2021 Jul 14.
Related Links
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Atkins Diet Weight Loss Program
Other Identifiers
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Pro00010519
Identifier Type: -
Identifier Source: org_study_id