title: Meal replacement reduces insulin requirement, HbA1c and weight long-term in type 2 diabetes patients with >100 U insulin per day.
abstract: BACKGROUND
  Despite high insulin doses, good glycaemic control is often lacking in type 2 diabetes patients and new therapeutic options are needed.
  
  
  METHODS
  In a proof of principle study, an energy-restricted, protein-rich meal replacement (PRMR) was examined as a means of reducing insulin requirement, HbA1C and body weight. Obese type 2 diabetes patients (n = 22) with >100 U insulin per day replaced, in week 1, the three main meals with 50 g of PRMR (Almased-Vitalkost) each (= 4903 kJ day(-1) ). In weeks 2-4, breakfast and dinner were replaced, and, in weeks 5-12, only dinner was replaced. Clinical parameters were determined at baseline, and after 4, 8 and 12 weeks, as well as after 1.5 years of follow-up. The Wilcoxon signed-rank test was used for the intention-to-treat analysis and the Mann-Whitney U-test for subgroup analyses.
  
  
  RESULTS
  The 12-week-programme was completed by 15 participants (68%). After 1 week, the mean insulin dose was reduced from 147 (75) U to 91 (55) U day(-1) (P = 0.0001), and to 65 (32) U (P < 0.0001) after 12 weeks of study. Over a period of 12 weeks, HbA1c decreased from 8.8% (1.4%) to 8.1% (1.6%) (P = 0.048) and weight decreased from 118.0 (19.7) kg to 107.4 (19.2) kg (P < 0.0001). Moreover, body mass index, waist and hip circumference, fasting blood glucose, triglycerides and high-density lipoprotein cholesterol improved significantly. After 1.5 years, insulin requirement and weight remained significantly lower than baseline. Participants who continued PRMR further reduced their HbA1c, weight and insulin dose. Two patients were able to stop insulin therapy altogether.
  
  
  CONCLUSIONS
  Energy-restricted PRMR was effective in reducing insulin requirement of type 2 diabetes patients with intensified insulin therapy accompanied by a reduction of HbA1c, weight and other cardiometabolic risk factors. With the continuous use of PRMR, glycaemic control might be improved in the long term.
authors.affiliation: West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Kempf
authors.forename: N C
authors.initials: NC
authors.lastname: Schloot
authors.forename: B
authors.initials: B
authors.lastname: Gärtner
authors.forename: R
authors.initials: R
authors.lastname: Keil
authors.forename: P
authors.initials: P
authors.lastname: Schadewaldt
authors.forename: S
authors.initials: S
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy*; D004032:Diet; D004044:Dietary Proteins / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005215:Fasting; D005260:Female; D005500:Follow-Up Studies; D005526:Food, Formulated; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007328:Insulin / Q000008:administration & dosage* / Q000097:blood; D008297:Male; D062407:Meals; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000178:diet therapy; D010865:Pilot Projects; D014280:Triglycerides / Q000097:blood
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004044:Dietary Proteins; D006442:Glycated Hemoglobin; D007328:Insulin; D014280:Triglycerides
keywords: HbA1c; insulin requirement; meal replacement; type 2 diabetes; weight