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Trial record 39 of 491 for:    Harvard

Diet, Adiposity, and Metabolic Alterations

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ClinicalTrials.gov Identifier: NCT03419455
Recruitment Status : Active, not recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mingyang Song, Harvard Medical School

Brief Summary:
Obesity is associated with increased risk of several cancers. Suggested mechanisms mediating the obesity-cancer associations include hyperinsulinemia and altered IGF signaling, changes in sex hormone levels as well as altered secretion of adipokines and inflammatory proteins. However, little is known about the influence of lifetime adiposity on the relevant biomarkers. Moreover, although diet has been suggested to ameliorate the adverse metabolic effects of obesity, convincing evidence regarding how dietary factors may influence obesity-related carcinogenic pathways remains lacking. Thus, in the current project, the investigators aim to 1) examine the associations between trajectories of body fatness and plasma biomarker levels of the insulin/IGF system, sex hormones and biomarkers of inflammatory response including adipokines; 2) investigate how nutritional factors may modulate these obesity-related biomarkers. The investigators propose to utilize two large ongoing cohorts of US men and women, the Nurses' Health Study and Health Professionals Follow-up Study.

Condition or disease Intervention/treatment
Obesity Lifelong Obesity Cancer Other: Trajectories of body fatness and diet

Detailed Description:

According to the International Agency for Research on Cancer (IARC), there is sufficient evidence that avoidance of weight gain reduces the risk of several cancers, including colorectal, breast (postmenopause), pancreatic, endometrial, kidney (renal-cell), liver, gallbladder, oesophageal (adenocarcinoma), multiple myeloma, meningioma, ovarian, thyroid and stomach (cardia) cancer. Several mechanisms have been suggested to mediate the obesity-cancer association, including increased insulin levels and bioavailability of insulin-like growth factor (IGF)-1, low-grade chronic inflammation, and changes in sex hormone levels.

In previous studies, the investigators have identified five heterogeneous trajectory groups of body fatness from age five and up to 60 years (lean-stable, lean-moderate increase, lean-marked increase, medium-stable, and heavy-stable/increase). These trajectories have been associated with distinct patterns of cancer incidence and mortality. Having excess body weight at any life period have been associated with increased risk of total and obesity related cancers. How the various trajectories of body shape relate to cancer relevant risk biomarkers is however yet to be determined.

To gain a better understanding of the complex interplay between obesity, obesity-related risk biomarkers and cancer development, the investigators aim to examine the associations between trajectories of body fatness and cancer relevant risk biomarkers in the Nurses' Health Study and Health Professionals Follow-up Study. Moreover, the investigators will examine how nutritional factors, such coffee intake, may modulate the levels of these biomarkers.

The investigators hypothesize that in general individuals who have excess body weight at any life period will have a more unfavorable biomarker profile than those who are lean across the lifespan, although a different pattern may be expected for some markers. Also, the investigators hypothesize that some nutritional factors, such high intake of coffee, may ameliorate the adverse metabolic effects of obesity by modulating the levels of these biomarkers.


Study Type : Observational
Actual Enrollment : 173230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diet, Adiposity, and Metabolic Alterations: a Prospective Observational Study of Three US Cohorts
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
Men
Health Professionals Follow-up Study: a prospective cohort of male health professionals
Other: Trajectories of body fatness and diet
There is no intervention. This is an observational study with trajectories of body fatness and diet as main exposure.

Women
Nurses' Health Study: a prospective cohort of female registered nurses
Other: Trajectories of body fatness and diet
There is no intervention. This is an observational study with trajectories of body fatness and diet as main exposure.




Primary Outcome Measures :
  1. Biomarkers of the insulin/IGF pathway [ Time Frame: Biomarkers assessed in the time period 1993-2015 for women and 2001-2014 for men ]
    Plasma biomarkers of insulin/IGF signalling, including C-peptide, IGF-1, IGFBP-1, IGFBP-3 and IGF-1/IGFBP-3 molar ratio

  2. Sex hormones [ Time Frame: Biomarkers assessed in the time period 1993-2015 for women and 2001-2014 for men ]
    Plasma estrone, estradiol, testosterone and sex hormone-binding globulin (SHBG)

  3. Biomarkers of inflammatory response [ Time Frame: Biomarkers assessed in the time period 1993-2015 for women and 2001-2014 for men ]
    Plasma CRP, IL-6, sTNFR2, adiponectin (total and HMW adiponectin), leptin and leptin receptor


Biospecimen Retention:   Samples Without DNA
Plasma samples to analyze for insulin/IGF signaling, sex hormones and inflammatory response


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The current project uses data from two large US cohort studies, the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS). The NHS recruited 121,701 registered female nurses aged 30 to 55 years at baseline in 1976, and the HPFS enrolled 51,529 male health professionals aged 40 to 75 years at baseline in 1986. Since enrollment, questionnaires have been administrated every two years to collect updated lifestyle and medical information. Blood samples were collected in 1989-90 in the NHS and 1993-95 in the HPFS. A total of 32 826 blood samples were returned in the NHS and 18 159 in the HPFS.
Criteria

Inclusion Criteria:

  • Adult health professionals

Exclusion Criteria:

  • History of diabetes, CVD and cancer (except melanoma skin cancer) at blood draw
  • Incomplete body fatness data
  • Biomarker levels considered as statistical outliers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419455


Sponsors and Collaborators
Harvard Medical School
Investigators
Principal Investigator: Walter C. Willett, MD, MPH, DrPH Harvard T. H. School of Public Health
  Study Documents (Full-Text)

Documents provided by Mingyang Song, Harvard Medical School:

Responsible Party: Mingyang Song, Principal Investigator, Harvard Medical School
ClinicalTrials.gov Identifier: NCT03419455     History of Changes
Other Study ID Numbers: 1999P011117/BWH
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to other researchers upon request, following the guidelines for the collaboration of external researchers with the Nurses' Health Study and Health Professionals Follow-up Study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After the data analysis is completed and the results published
Access Criteria: Written request sponsored by an HPFS or NHS investigator
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mingyang Song, Harvard Medical School:
Obesity
Lifelong Obesity
Metabolic abnormalties
Low-grade chronic inflammation
Hyperinsulinemia
IGF signalling
Sex hormones
Inflammatory response
Adipokines
Diet

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms