Clinical trial NCT03839667: Intensive Diet and Physical Activity on Diabetes
Official title: Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Life Style
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 326
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The trial will recruit 324 patients from 2-3 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 40-70 years; newly-diagnosed type 2 diabetes mellitus; BMI ≥25 kg/m2 and \<40 kg/m2. Main exclusion criteria include known type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of HbA1c changes between intensive intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims:

1. Recruit 324 study participants who meet the eligibility criteria and randomly assign 108 to the intensive diet intervention group, 108 to the enhanced physical activity intervention group and 108 to the standard education group for 12 weeks;
2. Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
3. Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
4. Perform strict quality control procedures for intervention and data collection;
5. Conduct data analysis according to the intention-to-treat principle;
6. Disseminate the study findings to influence clinical practice and clinical guidelines.

The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged 40-70 years;
2. Newly diagnosed type 2 diabetes

   * Duration of type 2 diabetes ≤ 2 years;
   * Antidiabetic treatment maintained for at least 6 weeks before recruitment;
3. 7.0%≤ HbA1c \< 9.0%;
4. 25 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

Exclusion Criteria:

1. History consistent with type 1 diabetes;
2. Insulin treatment;
3. Severe cardiovascular disease:

   * current angina
   * myocardial infarction within last six months
   * heart failure
   * symptomatic periphery vascular disease
4. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg;
5. Myocardial ischemia indicated by resting ECG;
6. Foot ulcers, peripheral neuropathy or skeletal disorders;
7. Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase
8. Average weekly alcohol intake \>140 grams for men and \>70 grams for women;
9. ALT or AST levels more than twice the upper limit of the normal range or active liver diseases;
10. eGFR \<60 ml/min/1.73 m2, or serum creatinine \>1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria
11. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
12. Hemoglobin concentration \<130 g/l for men or \<120 g/l for women;
13. Past or present confirmed psychiatric illness or drug dependence;
14. History of food allergies;
15. Surgical history of digestive system;
16. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
17. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
18. Known to have metabolism-affecting diseases;
19. Known to have infectious diseases within last month;
20. Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;
21. Other acute diseases supported by clinical evidence which may contradict to the interventions;
22. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
23. Currently participating in another intervention study;
24. Failure to obtain informed consent from participant;
25. Any factors judged by the clinic team to be likely to limit adherence to interventions;
26. Any other medical condition judged by the clinic team not eligible for the trial.

Primary outcomes:
measure: change in HbA1C level (%)
timeFrame: 12 weeks
Secondary outcomes:
measure: change in HbA1C level (%)
timeFrame: 1 year
measure: proportion of reversal of diabetes
timeFrame: 1 year
measure: reduction in the dosage of hypoglycemic drugs
timeFrame: 1 year
measure: change in insulin sensitivity
timeFrame: 1 year
measure: change in islet β-cell function
timeFrame: 1 year
measure: change in liver steatosis quantified by MRI-PDFF (percentage)
timeFrame: 1 year
measure: change in body mass index (BMI)
timeFrame: 1 year
measure: change in visceral fat (cm^2)
timeFrame: 1 year
measure: change in serum fetuin-A concentration (μg/mL)
timeFrame: 1 year
measure: change in serum GREM2 concentration (pg/ml)
timeFrame: 1 year
measure: change in serum Caspase-cleaved Keratin 1 concentration (U/L)
timeFrame: 1 year
measure: changes in serum FGF21 concentration (pg/ml)
timeFrame: 1 year
measure: changes in overall gut microbiota profile
timeFrame: 1 year
measure: depression
timeFrame: 1 year
measure: health related quality of life
timeFrame: 1 year
measure: cardiovascular risk
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: