T2DM
Conditions
Interventions
a whole grains and beans diet intervention with daily calorie restriction:A whole grains and beans diet intervention for 12 weeks, approximately 70% of their total energy requirements per day. The tar
a whole grains and beans diet intervention with daily calorie restriction:A whole grains and beans diet intervention for 12 weeks, approximately 100% of their total energy requirements per day. The ta
Control group with daily calorie restriction:A control diet intervention for 12 weeks, approximately 70% of their total energy requirements per day. The targeted percentages of energy derived from fat
Control group without calorie restriction:A control diet intervention for 12 weeks, approximately 100% of their total energy requirements per day. The targeted percentages of energy derived from fat,
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Voluntarily join and sign an informed consent form; Type 2 diabetes patients diagnosed within 6 years; 25 kg/m2=BMI; 18 years old = age<64 years old; Currently, insulin and GLP-1 drugs are not being used;
Exclusion criteria
Exclusion criteria: Type 1 diabetes, autoimmune diabetes, and other special types of diabetes (cortisolism, growth hormone tumor, glucagon tumor, and some special types of diabetes caused by genetic factors); Acute cardiovascular and cerebrovascular events or myocardial infarction within 12 months; Laboratory examination: Liver function AST and/or ALT = 2.5 × ULN; Renal function Cr>1.2 × ULN; Individuals with severe gastrointestinal diseases, such as active peptic ulcers, intestinal obstruction, etc; There is a change in the normal structure of the gastrointestinal tract Those who have a history of surgery; Hypertensive patients with poor blood pressure control (SBP = 160mmHg and/or DBP = 100mmHg); Individuals with severe hematological disorders; Those who have other endocrine system diseases, such as hyperthyroidism or Cushing's syndrome, in combination; Individuals with stress state or secondary factors of elevated blood glucose levels; Pregnant or lactating women, women who plan to conceive or do not wish to use contraception during the study period; Drug or other drug abusers; Individuals who have lost more than 5kg in weight in the past 3 months; Individuals who have participated in other drug trials within the past 3 months; Individuals with mental illnesses or other conditions who are unable to cooperate; Patients who have undergone metabolic surgery; In other cases, researchers believe that participants are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting blood-glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight and body composition;Cardiovascular risk factors, such as blood pressure, blood lipids, and other indicators;Inflammatory indicators;Sleep; | — |
Countries
China
Contacts
Public ContactKANG JUNREN
Department of Clinical Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed