Eva A Olausson1, Stine Störsrud1, Håkan Grundin2, Mats Isaksson2, Stig Attvall1, Magnus Simrén1. 1. Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska, Academy, University of Gothenburg, Gothenburg, Sweden. 2. Department of Radiation Physics, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Abstract
OBJECTIVES: Gastroparesis is a well-known complication to diabetes mellitus (DM). Dietary advice is considered to be of importance to reduce gastrointestinal (GI) symptoms in patients with diabetic gastroparesis, but no randomized controlled trials exist. Our aim was to compare GI symptoms in insulin treated DM subjects with gastroparesis eating a diet with small particle size ("intervention diet") with the recommended diet for DM ("control diet"). METHODS:56 subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or the control diet. The patients received dietary advice by a dietitian at 7 occasions during 20 weeks. GI symptom severity, nutrient intake and glycemic control were measured before and after the intervention. RESULTS: A significantly greater reduction of the severity of the key gastroparetic symptoms-nausea/vomiting (P=0.01), postprandial fullness (P=0.02) and bloating (P=0.006)-were seen in patients who received the intervention diet compared with the control diet, and this was also true for regurgitation/heartburn (P=0.02), but not for abdominal pain. Anxiety was reduced after the intervention diet, but not after the control diet, whereas no effect on depression or quality of life was noted in any of the groups. A higher fat intake in the intervention group was noted, but otherwise no differences in body weight, HbA1c or nutrient intake were seen. CONCLUSIONS: A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus. (ClinicalTrials.gov NCT01557296).
RCT Entities:
OBJECTIVES:Gastroparesis is a well-known complication to diabetes mellitus (DM). Dietary advice is considered to be of importance to reduce gastrointestinal (GI) symptoms in patients with diabetic gastroparesis, but no randomized controlled trials exist. Our aim was to compare GI symptoms in insulin treated DM subjects with gastroparesis eating a diet with small particle size ("intervention diet") with the recommended diet for DM ("control diet"). METHODS: 56 subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or the control diet. The patients received dietary advice by a dietitian at 7 occasions during 20 weeks. GI symptom severity, nutrient intake and glycemic control were measured before and after the intervention. RESULTS: A significantly greater reduction of the severity of the key gastroparetic symptoms-nausea/vomiting (P=0.01), postprandial fullness (P=0.02) and bloating (P=0.006)-were seen in patients who received the intervention diet compared with the control diet, and this was also true for regurgitation/heartburn (P=0.02), but not for abdominal pain. Anxiety was reduced after the intervention diet, but not after the control diet, whereas no effect on depression or quality of life was noted in any of the groups. A higher fat intake in the intervention group was noted, but otherwise no differences in body weight, HbA1c or nutrient intake were seen. CONCLUSIONS: A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus. (ClinicalTrials.gov NCT01557296).