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临床试验/NCT06682351
NCT06682351尚未招募4 期

Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

Stanford University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Change in HbA1c
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2
  • •HbA1c 5.7-8.0% while not on antihyperglycemic medications

排除标准

  • •Recent (<6mos) CVD event
  • •active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery
  • •history of acute pancreatitis
  • •family or personal history of medullary thyroid cancer
  • •current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
  • •heavy alcohol use
  • •hct <30, creatinine > 1.4, ALT> 3x ULN
  • •physical activity >2 hours/day
  • •inability to come to Stanford CTRU for metabolic testing

研究组 & 干预措施

Mediterranean Diet/GLP1a/Metformin

Experimental
  1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  2. 3 months washout
  3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  4. 3 months washout
  5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

干预措施: Metformin (Drug)

Mediterranean Diet/GLP1a/Metformin

Experimental
  1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  2. 3 months washout
  3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  4. 3 months washout
  5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

干预措施: GLP-1A (Drug)

Mediterranean Diet/GLP1a/Metformin

Experimental
  1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  2. 3 months washout
  3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  4. 3 months washout
  5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

干预措施: MED (Dietary Supplement)

Metformin/Mediterranean Diet/GLP1a

Experimental
  1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  2. 3 months washout
  3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  4. 3 months washout
  5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

干预措施: Metformin (Drug)

Metformin/Mediterranean Diet/GLP1a

Experimental
  1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  2. 3 months washout
  3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  4. 3 months washout
  5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

干预措施: GLP-1A (Drug)

Metformin/Mediterranean Diet/GLP1a

Experimental
  1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  2. 3 months washout
  3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
  4. 3 months washout
  5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

干预措施: MED (Dietary Supplement)

GLP1a/Metformin/Mediterranean Diet

Experimental
  1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  2. 3 months washout
  3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  4. 3 months washout
  5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.

干预措施: Metformin (Drug)

GLP1a/Metformin/Mediterranean Diet

Experimental
  1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  2. 3 months washout
  3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  4. 3 months washout
  5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.

干预措施: GLP-1A (Drug)

GLP1a/Metformin/Mediterranean Diet

Experimental
  1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
  2. 3 months washout
  3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
  4. 3 months washout
  5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.

干预措施: MED (Dietary Supplement)

结局指标

主要结局

Change in HbA1c

时间窗: At month 0, month 4, month 8, month 11, month 15, month 18

The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.

次要结局

  • Change in Time in Range (TIR)(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in body weight(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in Blood Pressure(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in LDL Cholesterol(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in Triglycerides(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in high-sensitivity C-reactive protein (hsCRP)(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in alanine transaminase (ALT)(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in adiponectin(At month 0, month 4, month 8, month 11, month 15, month 18)
  • HOMA-B(At month 0, month 4, month 8, month 11, month 15, month 18)
  • HOMA-IR(At month 0, month 4, month 8, month 11, month 15, month 18)
  • Change in body fat mass(At month 0, month 4, month 8, month 11, month 15, month 18)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tracey McLaughlin

Professor of Medicine (Endocrinology)

Stanford University

研究点 (1)

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