Trial · NCT00017953
Look AHEAD: Action for Health in Diabetes
NCT00017953, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2023-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Look AHEAD: Action for Health in Diabetes. Trials, record NCT00017953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00017953
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Look AHEAD: Action for Health in Diabetes
- NCT number
- NCT00017953
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,145 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Diabetes, Myocardial Infarction, Stroke, Kidney Diseases, Bone Diseases, Dyslipidemia
- Interventions
- Lifestyle Intervention, Diabetes Support and Education
- First posted
- 2001-06-21
- Last updated
- 2023-08-02
- Results first posted
- 2023-08-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First Occurrence of a Severe Cardiovascular Event | up to 11 years | Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths |
| Secondary | First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke | up to 11 years | Number of participants with first occurrence of one of the following: cardiovascular death, myocardial infarction (fatal or nonfatal), or stroke (fatal or non-fatal) |
| Secondary | First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina | up to 11 years | Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, or hospitalizations for angina |
| Secondary | First Occurrence of Major Clinical Events | up to 11 years | Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, hospitalization for angina, coronary artery bypass grafting, percutaneous coronary angioplasty, hospitalization for congestive heart failure, carotid endarterectomy, or peripheral vascular procedures such as bypass or angioplasty |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | First Occurrence of a Severe Cardiovascular Event | up to 11 years | Intent to Treat, all randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke | up to 11 years | Intent to treat, all randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina | up to 11 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | First Occurrence of Major Clinical Events | up to 11 years | Intent to treat, all randomized participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| First Occurrence of a Severe Cardiovascular Event | Lifestyle Intervention | 403 | Participants | ||
| First Occurrence of a Severe Cardiovascular Event | Diabetes Support and Education | 418 | Participants | ||
| First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke | Lifestyle Intervention | 267 | Participants | ||
| First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke | Diabetes Support and Education | 283 | Participants | ||
| First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina | Lifestyle Intervention | 496 | Participants | ||
| First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina | Diabetes Support and Education | 529 | Participants | ||
| First Occurrence of Major Clinical Events | Lifestyle Intervention | 577 | Participants | ||
| First Occurrence of Major Clinical Events | Diabetes Support and Education | 600 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lifestyle Intervention | 2,570 | |
| Overall Study | STARTED | Diabetes Support and Education | 2,575 | |
| Overall Study | COMPLETED | Lifestyle Intervention | 2,481 | |
| Overall Study | COMPLETED | Diabetes Support and Education | 2,476 | |
| Overall Study | NOT COMPLETED | Lifestyle Intervention | 89 | |
| Overall Study | NOT COMPLETED | Diabetes Support and Education | 99 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest pain/angina/heart pain | Cardiac disorders | Lifestyle Intervention | 858 | 2,570 | 2,299 |
| other | Chest pain/angina/heart pain | Cardiac disorders | Diabetes Support and Education | 899 | 2,575 | 2,444 |
| other | Abdominal pain, above and below | General disorders | Lifestyle Intervention | 1,480 | 2,570 | 4,910 |
| other | Abdominal pain, above and below | General disorders | Diabetes Support and Education | 1,520 | 2,575 | 5,374 |
| other | Constipation | Gastrointestinal disorders | Lifestyle Intervention | 1,858 | 2,570 | 8,384 |
| other | Constipation | Gastrointestinal disorders | Diabetes Support and Education | 1,838 | 2,575 | 8,095 |
| other | Diarrhea | Gastrointestinal disorders | Lifestyle Intervention | 1,840 | 2,570 | 7,413 |
| other | Diarrhea | Gastrointestinal disorders | Diabetes Support and Education | 1,896 | 2,575 | 7,968 |
| other | Dizzy or lightheaded, any | Cardiac disorders | Lifestyle Intervention | 1,884 | 2,570 | 8,042 |
| other | Dizzy or lightheaded, any | Cardiac disorders | Diabetes Support and Education | 1,886 | 2,575 | 8,177 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lifestyle Intervention | 174 | 2,570 |
| Total, all-cause mortality | Diabetes Support and Education | 202 | 2,575 |
| Total, other adverse events | Lifestyle Intervention | 2,493 | 2,570 |
| Total, other adverse events | Diabetes Support and Education | 2,488 | 2,575 |
| Total, serious adverse events | Lifestyle Intervention | 639 | 2,570 |
| Total, serious adverse events | Diabetes Support and Education | 596 | 2,575 |
Source ClinicalTrials.gov
Papers105
The papers the trial lists on ClinicalTrials.gov.
Grants16
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01DK056990 | 02/16 Action for Health in Diabetes Extension Study Research Study | GREENWAY, FRANK | LSU PENNINGTON BIOMEDICAL RESEARCH CTR | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK056992 | 12/16 Action for Health in Diabetes Extension Study Research Project | WING, RENA R | MIRIAM HOSPITAL | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057002 | 11/16 Action for Health in Diabetes Extension Study Research Project | JAKICIC, JOHN M | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057008 | 03/16 Action for Health in Diabetes Extension Study Research Project | LEWIS, CORA E | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057078 | 07/16 Action for Health in Diabetes Extension Study Research Project | JOHNSON, KAREN C | UNIVERSITY OF TENNESSEE HEALTH SCI CTR | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057131 | 14/16 Action for Health in Diabetes Extension Study Research Project | KAHN, STEVEN EMANUEL | SEATTLE INST FOR BIOMEDICAL/CLINICAL RES | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057135 | 10/16 Action for Health in Diabetes Extension Study Research Project | WADDEN, THOMAS A. | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057136 | 16/16 Action for Health in Diabetes Extension Study Biostatistics Research Center | ESPELAND, MARK ANDREW; WAGENKNECHT, LYNNE E | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057149 | Action for Health in Diabetes Continuation (Look AHEAD-E) | CLARK, JEANNE M | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
| U01DK057151 | 05/16 Action for Health in Diabetes Extension Study - Research Project | CATENACCI, VICTORIA A | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1999 to 2020 | NIH RePORTER |
1 to 10 of 16
See all 16 grantsTrial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lifestyle Intervention vs Diabetes Support and Education: First Occurrence of Major Clinical Events | Trial comparisons |
| Lifestyle Intervention vs Diabetes Support and Education: First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina | Trial comparisons |
| Lifestyle Intervention vs Diabetes Support and Education: First Occurrence of a Severe Cardiovascular Event | Trial comparisons |
| Lifestyle Intervention vs Diabetes Support and Education: deaths from any cause | Trial comparisons |
| Lifestyle Intervention vs Diabetes Support and Education: First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke | Trial comparisons |
| Lifestyle Intervention vs Diabetes Support and Education: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00017953
GET https://conductscience.org/api/trials/v1/NCT00017953/events?page=2