AFTER: Altering Fat Through Estrogen and Raloxifene

NCT00149604 | Completed Phase 2

• 2 other identifiers: AG0036R01AG018198
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether estrogens specifically promote a reduction in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal fat during weight gain.

Conditions

Postmenopause

Keywords

metabolic syndrome; hormone therapy; abdominal adiposity; lipolysis

Outcome Measures

Primary Outcomes (3)

• total body fat mass

• total abdominal fat area

• visceral abdominal fat area

Secondary Outcomes (9)

• fat-free mass

• total abdominal area

• resting metabolic rate

• dietary energy intake

• cardiovascular fitness

Interventions

conjugated estrogens DRUG

Raloxifene DRUG

exercise plus mild caloric restriction for weight loss BEHAVIORAL

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal women
• aged 50-70 yr
• healthy, as determined by medical history, physical examination, blood chemistries, and a graded exercise stress test with monitoring of blood pressure and ECG
• good cognitive function.

You may not qualify if:

• contraindications to estrogen or raloxifene treatment, including history of or active breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding, and active or history of blood clotting disorders
• mild or more severe cognitive impairment, indicated by a MMSE score \<26
• clinically significant abnormal resting electrocardiogram (ECG), angina and/or ECG evidence of acute myocardial ischemia during a maximal exercise stress test
• resting blood pressure above 150 mmHg systolic or 90 mmHg diastolic
• left bundle branch blocks, A-V block greater than first degree, clinically significant arrhythmias
• congestive heart failure
• pulmonary emboli in the previous 6 months
• aortic stenosis
• chronic infections
• orthopedic or other problems that would interfere with participation in the exercise program

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, 80262, United States

Location

Related Publications (4)

• Espeland MA, Stefanick ML, Kritz-Silverstein D, Fineberg SE, Waclawiw MA, James MK, Greendale GA. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen-Progestin Interventions Study Investigators. J Clin Endocrinol Metab. 1997 May;82(5):1549-56. doi: 10.1210/jcem.82.5.3925.

  PMID: 9141548 BACKGROUND

• Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14.

  PMID: 15252707 BACKGROUND

• Jensen LB, Vestergaard P, Hermann AP, Gram J, Eiken P, Abrahamsen B, Brot C, Kolthoff N, Sorensen OH, Beck-Nielsen H, Nielsen SP, Charles P, Mosekilde L. Hormone replacement therapy dissociates fat mass and bone mass, and tends to reduce weight gain in early postmenopausal women: a randomized controlled 5-year clinical trial of the Danish Osteoporosis Prevention Study. J Bone Miner Res. 2003 Feb;18(2):333-42. doi: 10.1359/jbmr.2003.18.2.333.

  PMID: 12568411 BACKGROUND

• Mattiasson I, Rendell M, Tornquist C, Jeppsson S, Hulthen UL. Effects of estrogen replacement therapy on abdominal fat compartments as related to glucose and lipid metabolism in early postmenopausal women. Horm Metab Res. 2002 Oct;34(10):583-8. doi: 10.1055/s-2002-35420.

  PMID: 12439787 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Estrogens, Conjugated (USP); Raloxifene Hydrochloride; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wendy M. Kohrt, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2000
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

US (1)