Evidence map›Paper›PMID 25707379›Full record

Trial reportObesity (Silver Spring, Md.)2015

Changes in body composition over 8 years in a randomized trial of a lifestyle intervention: the look AHEAD study.

Henry J Pownall, George A Bray, Lynne E Wagenknecht, Michael P Walkup, Stanley Heshka, Van S Hubbard, James Hill, Steven E Kahn, David M Nathan, Anne V Schwartz and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05275608 (Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation), which is not on this map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
–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.

NCT05275608 narecruitingnot on this mapstarted 2022, after this paper: background citation

Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome

TypeinterventionalSponsorAzienda Ospedaliero Universitaria Maggiore della CaritaRan2022 to 2025Enrolled40ConditionsDiabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic SyndromeArmsVLCKD diet with replacing meals, Hypocaloric mediterranean Diet
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  12. The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017
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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

12 authors.

Henry J PownallDepartment of Cardiology, Division of Atherosclerosis, Houston Methodist Research Institute and Baylor College of Medicine, Houston, Texas, USA.
George A Bray
Lynne E Wagenknecht
Michael P Walkup
Stanley Heshka
Van S Hubbard
James Hill
Steven E Kahn
David M Nathan
Anne V Schwartz
Karen C Johnson
Look AHEAD Research Group

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
Look AHEAD: Action for Health in DiabetesU01DK057136 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ESPELAND, MARK ANDREW, WAGENKNECHT, LYNNE E · 1999 to 2020
$54.9M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI WALDERS, NATALIE · 1985 to 2008
$52.6M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Julie Mathieu · 1986 to 2026
$41.4M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI HOGE, ELIZABETH A · 1985 to 2008
$37.4M
RESEARCH TRAININGP30DK026687 · NIDDK · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI Anthony W Ferrante, DYMPNA GALLAGHER · 1986 to 2026
$33.0M
PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI BRYAN C BERGMAN · 1995 to 2026
$32.6M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
WITHIN SUBJ VARIABILITY IN MEASUREMENTS DRUG METABOL ENZYMES IN HLTY SUBJM01RR000056 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LEVINE, ARTHUR S · 1985 to 2006
$29.2M
ZOLEDRONATE VS AREDIA IN MULTIPLE MYELOMA/BREAST CANCER W /BONE DISORDERSM01RR001346 · NCRR · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI PLISZKA, STEVEN R. · 1985 to 2008
$23.1M
SHOW PROJECTU01DK057154 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI NATHAN, DAVID M · 1999 to 2020
$23.1M
NCATS NIH HHS UL1 TR000170NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001120NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000056NCRR NIH HHS M01RR000056NCRR NIH HHS M01RR00051NCRR NIH HHS M01 RR001066NCRR NIH HHS M01 RR001346NCRR NIH HHS M01 RR002719NCRR NIH HHS M01RR01066NCRR NIH HHS M01RR01346NCRR NIH HHS M01RR02719NCRR NIH HHS UL1 RR024153NHLBI NIH HHS R01 HL030914NHLBI NIH HHS R01 HL056865NIDDK NIH HHS DK56990NIDDK NIH HHS DK56992NIDDK NIH HHS DK57002NIDDK NIH HHS DK57008NIDDK NIH HHS DK57078NIDDK NIH HHS DK57131NIDDK NIH HHS DK57135NIDDK NIH HHS DK57136NIDDK NIH HHS DK57149NIDDK NIH HHS DK57151NIDDK NIH HHS DK57154NIDDK NIH HHS DK57171NIDDK NIH HHS DK57177NIDDK NIH HHS DK57178NIDDK NIH HHS DK57182NIDDK NIH HHS DK57219NIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK026687NIDDK NIH HHS P30 DK046204NIDDK NIH HHS P30 DK048520NIDDK NIH HHS P30 DK48520NIDDK NIH HHS U01 DK056990NIDDK NIH HHS U01 DK056992NIDDK NIH HHS U01 DK057002NIDDK NIH HHS U01 DK057008NIDDK NIH HHS U01 DK057078NIDDK NIH HHS U01 DK057131NIDDK NIH HHS U01 DK057135NIDDK NIH HHS U01 DK057136NIDDK NIH HHS U01 DK057149NIDDK NIH HHS U01 DK057151NIDDK NIH HHS U01 DK057154NIDDK NIH HHS U01 DK057171NIDDK NIH HHS U01 DK057177NIDDK NIH HHS U01 DK057178NIDDK NIH HHS U01 DK057182NIDDK NIH HHS U01 DK057219
6 · The paper itself

Abstract

objectiveTo determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type 2 diabetes at baseline and at 1, 4, and 8 years.

methodsBody composition was measured by dual-energy X-ray absorptiometry in a subset of 1019 Look AHEAD study volunteers randomized to intervention or comparison groups. The intervention was designed to achieve and maintain ≥7% weight loss through increased physical activity and reduced caloric intake. The comparison group received social support and diabetes education.

resultsAt 1 year, the intervention group lost fat (5.6 ± 0.2 kg) and lean mass (2.3 ± 0.1 kg) but regained fat (∼100%) and lost lean mass between years 1 and 8. Between baseline and year 8, weight loss was greater in intervention versus comparison groups (4.0 ± 0.4 vs. 2.3 ± 0.4 kg); comparison group weight loss was mostly lean mass (2.1 ± 0.17 kg). Fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points.

conclusionsReduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae, a hypothesis that can be tested by future studies of this cohort.

Indexed as

Body CompositionLife StyleAbsorptiometry, PhotonAgedBehavior TherapyCaloric RestrictionDiabetes Mellitus, Type 2Exercise TherapyFemaleFollow-Up StudiesHumansMaleMiddle AgedObesityOverweightPatient Education as Topic

Identifiers

PMID25707379
PMCPMC4707962

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Registered trials

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.