Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The reasonable combination of macronutrients including carbohydrates, proteins and fat, is the basis of rational diet and beneficial to treatment of metabolic diseases including obesity and diabetes. Endocrine hormones play pivotal roles in regulation of nutrients metabolism and energy homeostasis. However, the dynamic metabolism following the consumption of macronutrients and the relationship between various metabolites and endocrine hormones during these procedures yet to be adequately explained nowadays. Therefore, in this study, the investigators selected glucose, protein, fat and mixed meal tolerance test (MMTT) for the loading tests, endocrine hormones and metabolites were detected to profile the molecular changes in the plasma. The investigators aimed to explore the nutrient processing patterns of various macronutrients and determine the interaction between metabolic hormones and metabolites.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macronutrients loading test for healthy group | Experimental | A total of 30 subjects with normal metabolic status underwent four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals. |
|
| Mixed meal tolerance test (MMTT) for healthy group | Experimental | A total of 40 subjects with normal weight and plasma glucose levels underwent MMTT. |
|
| Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose | Experimental | A total of 40 overweight subjects without a history of diabetes underwent MMTT. |
|
| Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose | Experimental | A total of 40 obese subjects without a history of diabetes underwent MMTT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macronutrients | Other | Four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolites | Plasma metabolites after dietary loading. | 0 to 180 minutes after a dietary loading |
| Endocrine hormones | Plasma insulin and C-peptide after dietary loading. | 0 to 180 minutes after a dietary loading |
| Proteomics | Plasma proteomics after dietary loading. | 0 to 180 minutes after a dietary loading |
| Lipidomics | Plasma lipidomics after dietary loading. | 0 to 180 minutes after a dietary loading |
| Diet questionnaire | Diet questionnaire | 3 days |
| Stool microbiome | Metagenomic sequencing and 16s microbiome sequencing | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of diabetes.
Pregnant or lactating women.
The subjects had not received oral/systemic corticosteroids for 7 consecutive days during the last 6 months.
Subjects were taking medication known to affect glucose metabolism.
Subjects who take strong inhibitors of cytochrome P450 (CYP)3A4/5, for example, ketoconazole, azanaway, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
Patients with either of the following characteristics of severe hepatic disease:
i. Two consecutive abnormal hepatic function results during recent four weeks, with ALT or AST three times the upper limit of the institutions normal reference ranges.
ii. Hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease.
iii. Acute viral hepatitis, autoimmune hepatitis, and alcoholic hepatitis
Patients with moderate and severe renal impairment, and end-stage renal disease (serum creatinine > 194.5 mmol/L, or serum potassium > 5.5 mmol/L).
New York Heart Association (NYHA) functional class III or IV congestive heart failure.
History of acute or chronic pancreatitis.
History of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers.
Subjects with previously diagnosed malignancy within the past 5 years.
Any other reasons that the investigator considered inappropriate to participate in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tao Yang, MD/PhD | First Affiliated Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2021 | Mar 2, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078622 | Nutrients |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mixed meal tolerance test (MMTT) | Other | Mixed meal tolerance test (MMTT) |
|