Trial reportPsychoneuroendocrinology2016

Testosterone and depressive symptoms among men in the Diabetes Prevention Program.

Catherine Kim, Elizabeth Barrett-Connor, Vanita R Aroda, Kieren J Mather, Costas A Christophi, Edward S Horton, Xavier Pi-Sunyer, George A Bray, Fernand Labrie, Sherita Hill Golden and 1 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychoneuroendocrinology, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 9 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% of its field
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.

Read, but not usablea number the graph found but could not read as for or against

Testosterone increasesmetformin vs placebodirection of benefit for this outcome is not defined · t2d, obesityfeeds one cell of the map
Δ -0.12<0.001
Testosterone increases were greater among men randomized to ILS vs. metformin vs. placebo (1.15nmol/l vs. -0.12nmol/l vs. -0.27nmol/l, p<0.001).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Metformin×inflammation & biomarkers

No readable resultOpen on the map →What to test next →

3 readable studies in this cell: 1 favour the treatment, 2 find no difference, 0 favour the comparator.

Belief with this paper
0.50one trial · 1 family supports, 0 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT00386100688 enrolled · 2006
Δ 1.47-14.8 to 20.8
NCT00727857600 enrolled · 2007
Δ 4.88-4.71 to 14.0

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

5 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Ginger and Testosterone.Biomolecules · 2018
    Review
  8. Review
  9. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

11 authors at 10 institutions in 2 countries.

Catherine KimUniversity of Michigan, Ann Arbor, MI, United States. Electronic address: cathkim@umich.edu.
Elizabeth Barrett-ConnorUniversity of California San Diego, La Jolla, CA, United States.
Vanita R ArodaMedStar Health Research Institute, Hyattsville, MD, United States.
Kieren J MatherIndiana University, Indianapolis, IN, United States.
Costas A ChristophiGeorge Washington University, Rockville, MD, United States.
Edward S HortonJoslin Diabetes Center, Boston, MA, United States.
Xavier Pi-SunyerColumbia University, New York City, NY, United States.
George A BrayLouisiana State University, Baton Rouge, LA, United States.
Fernand LabrieEndoceutics, Quebec, Canada.
Sherita Hill GoldenJohns Hopkins University, Baltimore, MD, United States.
Diabetes Prevention Program Research Group
Columbia University · USGeorge Washington University · USIndiana University – Purdue University Indianapolis · USJohns Hopkins University · USJoslin Diabetes Center · USLouisiana State University · USMedStar Health · USTheratechnologies (Canada) · CAUniversity of California San Diego · USUniversity of Michigan · US

Funding

PRIMARY PREVENTION TRIAL--DATA COORDINATING CENTERU01DK048489 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI JABLONSKI, KATHLEEN ANN, TEMPROSA, MARINELLA · 1994 to 2021
$84.8M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Karin E Bornfeldt · 1986 to 2026
$41.4M
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
Regional Pilot And Feasibility Study Grants ProgramP30DK020572 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Mehboob A Hussain · 2013 to 2026
$24.3M
Post-DDP Follow-up StudyU01DK048413 · NIDDK · UNIVERSITY OF WASHINGTON · PI KAHN, STEVEN EMANUEL · 1994 to 2021
$13.7M
PRIMARY PREVENTION TRIAL (DPT-2)U01DK048397 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI NATHAN, DAVID M · 1994 to 2021
$12.0M
NIDDM PRIMARY PREVENTION TRIAL (DPT 2)U01DK048404 · NIDDK · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI LAFERRERE, BLANDINE B · 1994 to 2021
$11.6M
PRIMARY PREVENTION TRIAL (DPT-2)U01DK048339 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ARANETA, MARIA ROSARIO GORREZ, MUDALIAR, SUNDER · 1994 to 2022
$11.4M
NIDDM PRIMARY PREVENTION TRIALU01DK048412 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI VENDITTI, ELIZABETH MARY · 1994 to 2021
$11.4M
PRIMARY PREVENTION TRIALU01DK048387 · NIDDK · MEDSTAR RESEARCH INSTITUTE · PI MAGEE, MICHELLE FISCHMANN · 1994 to 2022
$11.1M
TITLE OMITTEDU01DK048349 · NIDDK · YESHIVA UNIVERSITY · PI CRANDALL, JILL P · 1994 to 2021
$11.0M
PRIMARY PREVENTION TRIALU01DK048443 · NIDDK · UNIVERSITY OF SOUTHERN CALIFORNIA · PI WATSON, KAROL E · 1994 to 2021
$10.2M
NCATS NIH HHS UL1 TR001409NIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK020572NIDDK NIH HHS P30 DK092926NIDDK NIH HHS R01 DK072041NIDDK NIH HHS R01 DK078907NIDDK NIH HHS R01 DK083297NIDDK NIH HHS U01 DK048339NIDDK NIH HHS U01 DK048349NIDDK NIH HHS U01 DK048375NIDDK NIH HHS U01 DK048377NIDDK NIH HHS U01 DK048380NIDDK NIH HHS U01 DK048381NIDDK NIH HHS U01 DK048387NIDDK NIH HHS U01 DK048397NIDDK NIH HHS U01 DK048400NIDDK NIH HHS U01 DK048404NIDDK NIH HHS U01 DK048406NIDDK NIH HHS U01 DK048407NIDDK NIH HHS U01 DK048411NIDDK NIH HHS U01 DK048412NIDDK NIH HHS U01 DK048413NIDDK NIH HHS U01 DK048434NIDDK NIH HHS U01 DK048437NIDDK NIH HHS U01 DK048443NIDDK NIH HHS U01 DK048468NIDDK NIH HHS U01 DK048485NIDDK NIH HHS U01 DK048489NIDDK NIH HHS U01 DK048514
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectiveWe examined associations between intensive lifestyle intervention (ILS) and changes in testosterone and associations with mood among middle-aged men.

designSecondary analysis of men (n=886) participating in the Diabetes Prevention Program which randomized glucose-intolerant, overweight men to ILS, metformin, or placebo between 1996 and 1999.

main outcome measuresChanges in testosterone between baseline and 1-year follow-up asnd associations of these changes with mood measures (Beck Depression Inventory [BDI-II], Beck Anxiety Inventory [BAI]).

resultsMedian baseline testosterone was 10.98nmol/l and 44% (n=385) had testosterone<10.41nmol/l or 300ng/dl. Testosterone increases were greater among men randomized to ILS vs. metformin vs. placebo (1.15nmol/l vs. -0.12nmol/l vs. -0.27nmol/l, p<0.001). The association between changes in testosterone and mood differed by study arm (p<0.001 for interaction); there were no significant associations between changes in testosterone and mood changes among men in the ILS or placebo arms. Among men in the metformin arm, increases in testosterone were significantly associated with decreases in BDI-II (improved depressive symptoms) (β-coefficient -0.2336, p=0.0002) indicating a 0.23 decrease in BDI-II for every 1nmol/l increase in testosterone and decreases in BAI (improved anxiety symptoms) (β-coefficient -0.2147, p=0.0014). Similar patterns were observed for bioavailable testosterone.

conclusionsAmong overweight middle-aged men with glucose-intolerance, ILS increased endogenous testosterone slightly but without significant improvements in mood. Metformin did not increase testosterone, but among metformin users, testosterone increases were associated with improvements in mood. Thus, interventions that increase endogenous testosterone may not also improve mood.

Indexed as

Outcome Assessment, Health CareAdultDepressionDiabetes MellitusFollow-Up StudiesGlucose Metabolism DisordersHumansHypoglycemic AgentsMaleMetforminMiddle AgedOverweightTestosteroneWeight Reduction ProgramsHypoglycemic AgentsMetforminTestosteroneAndrogensGlucose-intoleranceMoodTestosterone

Identifiers

PMID27371769
PMCPMC5070975
OpenAlexW2440204022

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
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 OpenQuestion graph.