Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus (DiNA-D)
Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
연구 개요
상세 설명
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Berlin, 독일, 12203
- 모병
- German Institute for Human Nutrition, Department for Clinical Nutrition
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연락하다:
- Stefan Kabisch, Dr. med.
- 전화번호: 429 030 450 514
- 이메일: stefan.kabisch@charite.de
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연락하다:
- Ulrike Kaiser, M.sc.
- 전화번호: 428 030 450 514
- 이메일: ulrike.kaiser@charite.de
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부수사관:
- Stefan Kabisch, Dr. med.
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부수사관:
- Ulrike Kaiser, M.sc.
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, 독일, 14458
- 아직 모집하지 않음
- German Institut for Human Nutrition; Department for Clinical Nutrition
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연락하다:
- Margrit Kemper, Dr. med.
- 전화번호: 033200 88 2775
- 이메일: margrit.kemper@dife.de
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연락하다:
- Silke Hornemann
- 전화번호: 033200 88 2779
- 이메일: silke.hornemann@dife.de
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부수사관:
- Margrit Kemper, Dr. med.
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부수사관:
- Silke Hornemann
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부수사관:
- Christiana Gerbracht, Dr.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- male and female subjects
- 18-79 years old
- type 2 diabetes
Exclusion Criteria:
- renal insufficiency
- anaemia
- immunosuppression
- previous symptomatic cancer diagnosis
- acute cardiovascular disease (stroke, coronary syndrome)
- pregnancy and lactation
- severe psychiatric disorders
- corticoid or other immunosuppressive therapy
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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활성 비교기: low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
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first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
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활성 비교기: very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx.
1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
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first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change in insulin secretion (glucagon stimulation test)
기간: 3 weeks, 1 year
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change in insulin secretion (glucagon stimulation test)
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3 weeks, 1 year
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change in hepatic fat content (MR-S)
기간: 3 weeks, 1 year
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change in hepatic fat content (MR-S)
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3 weeks, 1 year
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change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
기간: 3 weeks, 1 year
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change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
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3 weeks, 1 year
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change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
기간: 3 weeks, 1 year
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change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
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3 weeks, 1 year
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change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
기간: 3 weeks, 1 year
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change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
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3 weeks, 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
기간: 3 weeks, 1 year
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inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)
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3 weeks, 1 year
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change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
기간: 3 weeks, 1 year
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peripheral neuropathy
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3 weeks, 1 year
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change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
기간: 3 weeks, 1 year
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autonomic neuropathy
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3 weeks, 1 year
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Andreas F.H. Pfeiffer, Prof. Dr. med., German Institute of Human Nutrition
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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