- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00229229
Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease
Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease
Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load.
To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet.
The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.
연구 개요
상태
상세 설명
The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se.
A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
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Ontario
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Kingston, Ontario, 캐나다, K7L 5G2
- Vascular Disease Prevention and Research Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women, aged 18 to 80 years
- BMI 25-40 kg/m2
Documented Cardiovascular Disease as evidenced by one or more of the following:
- Coronary atherosclerosis during coronary angiography
- Documented myocardial infarction
- Carotid atherosclerosis during carotid ultrasonography
- Carotid atherosclerosis during CT angiography
- Carotid atherosclerosis during MR angiography
- Ischemic brain infarct documented on brain imaging studies
Exclusion Criteria:
- Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada)
- Previous (<5 years ago) individual or group dietary counseling with a registered dietician
- Pregnant or lactating women
- Presence of clinically important hepatic or renal disease
- Inability to communicate effectively using the English language
- Enrollment in another study concurrently
- Inability to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 1
Low glycemic load diet
|
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
|
|
다른: 2
Canada Food Guide Diet
|
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
|
|
다른: 3
Low glycemic index diet
|
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
|
|
다른: 4
Low carbohydrate diet
|
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen A LaHaye, MD, Vascular Disease Prevention and Research Centre
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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