NCT03839667Fut, nem toboroz
Intensive Diet and Physical Activity on Diabetes
Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 12.
Rövid összefoglaló (regiszter, angolul)
It is a multicenter, open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll newly diagnosed type 2 diabetes patients with overweight or obesity. The patients are randomized to an intensive diet intervention (intermittent very-low -calorie diet), enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial will test the primary hypothesis of whether an intensive lifestyle treatment (diet or physical activity) is more effective than a standard education in glycemic control. The secondary hypotheses are to compare the intensive lifestyle treatment with a standard education on adipose distribution, metabolic parameters, metabolic molecules, Framingham Risk Scores, and quality of life, et al.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 326 (tényleges)
- Első benyújtás
- 2019. jan. 6.
- Kezdés
- 2019. jan. 7.
- Elsődleges befejezés
- 2021. jún. 17.
- Fő szponzor
- Shanghai Jiao Tong University School of Medicine
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT03839667
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 326
- 2019. jan. 7. és az elsődleges befejezés (2021. jún. 17.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
Más betegség
- History consistent with type 1 diabetes;
- Severe cardiovascular disease:
- current angina
- myocardial infarction within last six months
- heart failure
- symptomatic periphery vascular disease
- Uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg;
- Myocardial ischemia indicated by resting ECG;
- Foot ulcers, peripheral neuropathy or skeletal disorders;
- Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
- Past or present confirmed psychiatric illness or drug dependence;
- History of food allergies;
- Surgical history of digestive system;
- Known to have metabolism-affecting diseases;
- Known to have infectious diseases within last month;
- Other acute diseases supported by clinical evidence which may contradict to the interventions;
- Failure to obtain informed consent from participant;
- Any other medical condition judged by the clinic team not eligible for the trial.
Laborértékek
- ALT or AST levels more than twice the upper limit of the normal range or active liver diseases;
- eGFR <60 ml/min/1.73 m2, or serum creatinine >1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria
- Hemoglobin concentration <130 g/l for men or <120 g/l for women;
- Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
- Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;
Egyéb
- Insulin treatment;
- Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase
- Average weekly alcohol intake >140 grams for men and >70 grams for women;
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Currently participating in another intervention study;
- Any factors judged by the clinic team to be likely to limit adherence to interventions;
Kiket keres a vizsgálat
- Men and women aged 40-70 years;
- Newly diagnosed type 2 diabetes
- Duration of type 2 diabetes ≤ 2 years;
- Antidiabetic treatment maintained for at least 6 weeks before recruitment;
- 7.0%≤ HbA1c < 9.0%;
- 25 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
Életkor a regiszterben: 40 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Kína | Ismeretlen állapot |
Kapcsolódó publikációk
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.