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临床试验/CTRI/2018/06/014409
CTRI/2018/06/014409进行中(未招募)未知

Impact of nutritional and lifestyle modification in subjects with BMI 25-29.9kg/m2 vs 30-34.9kg/m2 and to assess the effect of bariatric surgery in BMI â?¥35kg/m2

Prof Sandeep Aggrawal0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Inclusion Criteria for first cohort (Group I):
  • a) Adult aged between 18-65 yrs
  • b) BMI 25-29.9 kg/m2
  • Inclusion Criteria for second cohort (GroupII):
  • a)Adult aged between 18-65 yrs
  • b)Normal adult BMI >29.9 kg/m2 to 34.9 kg/m2
  • Inclusion criteria for nonsurgical intervention in morbidly obese group:
  • a)BMI >=35 kg/m2
  • b)Adult aged between 18-65 yrs
  • Inclusion criteria for surgical intervention in
  • morbidly obese group:
  • a)Adult aged between 18-65 yrs
  • b)BMI >=35 kg/m2 with co-morbidities or BMI >=40 kg/m2
  • c)All non surgical measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 month
  • d)Patient with no psychological or clinical contraindications to anesthesia or surgery
  • e)Patient who have comprehension and commitment to long term follow up

排除标准

  • Exclusion Criteria for first cohort (Group I):
  • 1)Age below 18 yrs and above 65yrs
  • 2)BMI >29.9kg/m2
  • 3)Pregnant or lactating mothers
  • 4)Acute or severe chronic illness or severe end organ damage
  • 5)Patient is on some drug/s which can lead to hyperglycemia
  • 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake
  • 7)Patient who refuse consent for the study
  • Exclusion Criteria for second cohort (Group II)
  • 1)Age below 18 yrs and above 65yrs
  • 2)BMI >=35kg/m2
  • 3)Pregnant or lactating mothers
  • 4)Acute or severe chronic illness or severe end organ damage
  • 5)Patient is on some drug/s which can lead hyperglycemia
  • 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake
  • 7)Patient who refuse consent for the study
  • Exclusion criteria for nonsurgical intervention in morbidly obese group:
  • 1)BMI <35 kg/m2
  • 2)Age below 18 yrs and above 65yrs
  • 3)Pregnant or lactating mothers
  • 4)Acute or severe chronic illness or severe end organ damage
  • 5)Patient is on some drug/s which can lead hyperglycemia
  • 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake
  • 7)Patient who refuse consent for the study
  • Exclusion criteria for surgical intervention for morbidly obese group:
  • 1)Age below 18 yrs and above 65yrs
  • 2)BMI >=35 kg/m2 without co-morbidities or BMI <40 kg/m2
  • 3)Pregnant or lactating mothers
  • 4)Young female patients who have plan to extend family in next 2 years
  • 5)Acute or severe chronic illness or severe end organ damage
  • 6)Patient is on some drug/s which can lead hyperglycemia
  • 7)Secondary cause of obesity: any endocrinological dysfunction, drug intake
  • 8)Patient who are high risk for surgery
  • 9)Patient who refuse consent for the study

研究者

发起方
Prof Sandeep Aggrawal

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