ISRCTN15487120进行中（未招募）未知
Remission of diabetes and improved diastolic function by combining structured exercise with meal replacement and food reintroduction: the RESET for Remission trial
niversity of Leicester0 个研究点目标入组 100 人开始时间: 2021年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36130753/ (added 22/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 24/08/2022:
- •1. Age 18 to 45 years, inclusive
- •2. Type 2 diabetes: physician diagnosis more than 3 months and less than 6 years previously
- •3. Hemoglobin A1c 6.5% to 10%, inclusive if not taking glucose-lowering medication; 6.0% to 10% if taking glucose-lowering medication
- •4. Body mass index 30 kg/m² to 45 kg/m², inclusive if White or Indigenous¹, 27 kg/m² to 45 kg/m², inclusive if other background, including mixed
- •5. Weight stability: weight changes of less than 5 kg over the prior 6 months
- •6. Walking ability: able to walk without assists and to participate in structured exercise training requiring the lower limbs
- •7. Capacity: able to understand written and spoken English and/or French
- •8. Able to provide informed consent
- •9. Willing to be randomized and able to participate
- •10. Willing to attend supervised exercise sessions, if so randomized
- •11. Willing to adopt low energy diet, including abstinence from alcohol, if so randomized
- •12. Willing to self-monitor glucose and blood pressure at the required frequency, if randomized to the low energy diet plus supervised exercise arm
- •¹Term for the original peoples of North America and their descendants; includes First Nations, Inuit, and Métis peoples
- •²An exception is made for women who are on insulin therapy in case of pregnancy occurrence because of insulin’s established safety profile in pregnancy, rather than because of inability to control glycemia on oral agents alone. If these women are willing and able to use a reliable form of contraception, they may be enrolled.
- •Previous inclusion criteria:
- •1. Age 18 to 40 years, inclusive
- •2. A clinically coded diagnosis of T2DM between 3 months and 6 years previously
- •3. HbA1c 6.5% (48 mmol/mol) to 10% (86 mmol/mol), inclusive, within the last 12 months
- •4. BMI =30 kg/m² and =45 kg/m² (= 27.0 kg/m² if BAME (self-identified)), within the last 12 months
- •5. Self-reported stable weight over the previous 6 months (<+/- 5 kg)
- •6. Treatment stable; no significant change to glucose-lowering regimen in the preceding 3 months, as determined by a study investigator
- •7. Able to provide informed consent
- •8. Able to understand written and spoken English
- •9. Able to take part in structured exercise training requiring the lower limbs (e.g., able to walk without assists or impairment)
排除标准
- •Current exclusion criteria as of 24/08/2022:
- •1. Other diabetes types:
- •1.1. Type 1 diabetes
- •1.2. Gestational diabetes
- •1.3. Monogenic diabetes
- •2. Poorly controlled blood pressure: resting systolic blood pressure greater than 150 mmHg or resting diastolic blood pressure greater than 90 mmHg diastolic
- •3. Weight loss interventions: currently participating in a weight reduction program in addition to routine care
- •4. Previous bariatric surgery
- •5. Medications:
- •5.1. Insulin therapy²
- •5.2. Use of licensed weight loss medications
- •5.3. Significant changes in glucose-lowering medications in the prior 3 months, as judged by study physicians
- •5.4. Steroids by mouth or injection
- •6. Allergies: self-reported allergies or intolerances to components of the meal replacement products (e.g., milk protein allergy)
- •7. Dietary practices that prohibit the use of meal replacement products
- •8. Pregnancy, lactation or planning to become pregnant in the next 8 months
- •9. Eating disorder: self-reported or diagnosed
- •10. Substance abuse: alcohol, drugs
- •11. Estimated glomerular filtration rate: less than 60 ml.min-1 per 1.73m²
- •12. Retinopathy: receiving or requiring active treatment for retinopathy
- •13. Clinically manifest vascular disease:
- •13.1. Myocardial infarction
- •13.2. Stroke
- •13.3. Peripheral vascular disease
- •14. Other cardiac disease:
- •14.1. Heart failure
- •14.2. Atrial fibrillation
- •14.3. Pacemaker
- •14.4. Implantable cardioverter defibrillator (ICD)
- •15. Other conditions that could impact weight and/or safety: active malignancy or other chronic disease
- •16. Run-in phase:
- •16.1. Failure to complete at least 5 or requested 7 days of accelerometer wear
- •16.2. Failure to complete a food diary for three weekdays and one weekend day
- •Previous exclusion criteria:
- •1. Individuals with type 1, gestational or monogenic diabetes mellitus
- •2. On insulin therapy (An exception may be made for women who are on insulin therapy in case of pregnancy occurrence because of insulin’s established safety profile in pregnancy, rather than because of inability to control glycaemia on oral agents alone. If these women are willing and able to use a reliable form of contraception, they may be enrolled.)
- •3. eGFR <60 ml.min-1 per 1.73m²
- •4. Currently participating in a weight reduction program in addition to routine care
- •5. Previous bariatric surgery
- •6. Currently on injected steroids
- •7. Currently on weight loss medications (not including glucose-lowering medication)
- •8. Conditions that could impact weight (i.e., active malignancy/treatment in past year, pregnancy, lactation, planning to become pregnant in next 8 months)
- •9. Individuals with a self-reported or diagnosed eating disorder
- •10. Self-reported milk protein allergy or other allergy or dietary practice that prohibits the use of meal replacement products
- •11. Previous myocardial infarction, stroke, amputation secondary to T2DM/peripheral vascular disease, or other evidence of clinically manifest vascular disease
- •12. Previous clinically diagnosed atrial fibrillation
- •13. Previous clinically diagnosed heart failure
- •14. Pacemaker or implantable cardioverter-defibrillator (ICD)
- •15. Substance abuse. The requirement for alcohol abstinence during the initial 12 weeks will make it unlikely that individuals with alcohol dependence will enrol. Substance abuse will be queried.
- •16. Average resting blood pressure >150 mmHg systolic and/or >90 mmHg diastolic. In the case of borderline hypertension, individuals will be offered the opportun
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