- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01729117
A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.
Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.
Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.
Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.
Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90022
- Roybal Diabetes Management Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Demographic
- Age >18 years
- Enrolled in the Roybal Diabetes Management Clinic
- Self-described as Hispanic
- Willing and able to participate in Spanish language group sessions.
- Willing and able to attend study visits for the duration of the study at the allocated times.
- Willing and able to maintain a food exercise and medication log and perform and record self-monitoring of blood glucose (SMBG) Clinical
- T2DM diagnosed by fasting blood glucose >126mg/dL or random blood glucose >200mg/dL
- BMI>30 kg/m2
- If a woman of childbearing potential, using effective contraception. Biochemical HbA1c 8%-12% Medication
- On insulin therapy
Exclusion Criteria:
Medical conditions
- Type 1 DM
- Illness likely to lead to unstable weight or altered glucose control.
- Proliferative diabetic retinopathy on eye examination within the last 6 months.
- Gallstones suspected on clinical history or documented on ultrasound.
- Serum creatinine >1.5mg/dL
- Symptomatic cardiovascular disease
- Documented liver disease other than fatty liver
- Lactating, pregnant or intending to become pregnant within the following year Psycho-social conditions
- Inability or unwillingness to participate in a Spanish-language lifestyle group.
- Eating disorder such as bulimia
- Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar disorder.
- Inability to attend scheduled appointments regularly for the duration of the study Medication use
- Use of weight loss medication within previous 3 months including exenatide.
- Use of medication (other than diabetes medication) likely to lead to unstable weight or altered glucose control
- Laxative or substance abuse
- More than 10 alcoholic drinks/week
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Meal Replacement
Meal Replacements will be provided to participants randomized to the MR group
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5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
다른 이름들:
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다른: Standard Care
Standard Care participants will receive standard care but no meal replacements
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Standard Care only
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in BMI
기간: 12months
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12months
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2차 결과 측정
결과 측정 |
기간 |
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Severe Hypoglycemic Events
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elizabeth O Beale, MD, University of Southern California
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Meal Replacement에 대한 임상 시험
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Biomimedica, Inc종료됨