Evidence map›Paper›PMID 40950479›Full record

ArticlemedRxiv : the preprint server for health sciences2025

Heterogeneity of effect of Intensive lifestyle intervention on cardiometabolic risk factors by sex hormones in diabetes.

Chigolum P Oyeka, Jianqiao Ma, Jiahuan Helen He, Nityasree Srialluri, Teresa Gisinger, Erin D Michos, Mark Woodward, Rita R Kalyani, Jeanne M Clark, Wendy L Bennett and 1 more

Abstract readPreprint
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Chigolum P OyekaDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4102-3172
Jianqiao MaDepartment of Pediatrics, Division of General Pediatrics, Johns Hopkins University, Baltimore, Maryland.
Jiahuan Helen HeDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Nityasree SrialluriDivision of Nephrology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.
Teresa GisingerDivision of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna.
Erin D MichosDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.ORCID 0000-0002-5547-5084
Mark WoodwardThe George Institute for Global Health, School of Public Health, Imperial College London, London, UK.ORCID 0000-0001-9800-5296
Rita R KalyaniDepartment of Medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore, MD.
Jeanne M ClarkDepartment of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.ORCID 0000-0003-1194-0092
Wendy L BennettDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0001-9828-0706
Dhananjay VaidyaDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

Funding

STUDY OF HEALTH OUTCOMES OF WEIGHT-LOSS (SHOW)U01DK057149 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI CLARK, JEANNE M · 1999 to 2020
$17.4M
The Effect of Sex Hormones on Cardiometabolic Outcomes in Men and Women with Diabetes: The Look AHEAD (Action for Health in Diabetes) StudyR01DK127222 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI BENNETT, WENDY LYNET, VAIDYA, DHANANJAY MADHUKAR · 2020 to 2024
$2.5M
NIDDK NIH HHS R01 DK127222NIDDK NIH HHS U01 DK057149
6 · The paper itself

Abstract

Background: Intensive lifestyle intervention(ILI) in type 2 diabetes(T2D) improves cardiometabolic risk factors. Sex differences in these responses may be driven by the sex hormones testosterone(T), estradiol(E2), and sex hormone binding globulin(SHBG). We evaluated whether baseline sex hormone levels modify ILI effects on cardiometabolic risk factors ie, heterogeneity of treatment effect(HTE), and whether these modifications differ by sex. Methods: Study included 2,260 Look AHEAD participants(1,093 postmenopausal females; 1,167 males, mean age 60 years) randomized to ILI or diabetes support and education with sex hormone measurements. We used linear mixed-effects models, stratified by sex and adjusted for age, race, study site, medications and baseline weight, to examine the association between baseline T, E2, and SHBG with change in lipids, hemoglobin A1c(HbA1c), systolic and diastolic blood pressure(BP), weight, and waist circumference(WC) over an 8-year follow-up. HTE was assessed using a three way interaction term between baseline hormone levels, time and randomization arm. Permutation tests controlled for multiple comparisons. Results: In males, lower baseline E2 and total T significantly augmented ILI-induced triglyceride reductions(p=0.019 and 0.008, respectively) throughout follow up. Higher SHBG enhanced LDL-C lowering in females(p=0.018) and HDL-C increases in males(p=0.043). Higher baseline total T predicted greater long-term weight(p=0.013 females; 0.003 males) and WC loss(p=0.061 females; 0.035 males), while fewer hormone interactions were observed for BP and HbA1c. Conclusions: Males with greater endogenous total T achieved larger reductions in triglycerides, weight, and WC, whereas females with higher total T had greater HDL-C improvements and those with higher SHBG experienced more BP lowering. Hormone profiling may guide personalized lifestyle prescriptions to improve long term cardiometabolic benefits.

Identifiers

PMID40950479
PMCPMC12424865

What Socratic holds

Textmetadata
LicenceCC BY-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.