Acromegaly
Conditions
Interventions
All ten subjects received eucaloric ketogenic diet for two weeks (see figure 1
protocol). During this ad libitum ketogenic diet, emphasis is placed on
polyunsaturated and monounsaturated fats (diet
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Written informed consent male or female aged * 18. -Documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor -The patient is treated with lanreotide Autogel or octreotide long-acting release (LAR) on maximum doses for at least 6 months and has a serum IGF-I level above 120% of the age- and sex adjusted normal limits. -Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol.
Exclusion criteria
Exclusion criteria: - Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry. - It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. - Has a history of epilepsy - Has been treated with any unlicensed drug within the last 30 days before study entry. - Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. - Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjects safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. - Diabetes type 1 or diabetes type 2 and using insulin - Use of systemic corticosteroids within 60 days prior to screening - Females of childbearing potential must be using contraception (we do not perform a pregnancy test), otherwise excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of two weeks eucaloric ketogenic diet on GH and IGF-I levels in acromegaly patients. The primary endpoints are the difference in GH and IGF-I levels before and after 2 weeks of ketogenic diet. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to evaluate whether ketogenic diet, might have a: * blood glucose lowering effect; * positive effect on the insulin secretion; * induces weight loss; * positive effect on the lipid profile, especially on triglycerides and free fatty acids * broad safety range This secondary objectives are measured by the following efficacy and safety parameters: Blood biochemistry: (t0 =baseline, t1= week 1 and t2= week 2) * IGF-1 levels * GH levels * IGF-BP1 levels * Fasting plasma glucose, insulin, HbA1c levels, HOMA-IR * Total cholesterol, HDL-cholesterol and LDL-cholesterol levels * Triglycerides, free fatty acids * AST, ALT, alkaline phosphatase, gamma-glutamyltransferase, lactate dehydrogenase (LDH) Note: all the following laboratory evaluations will be performed at the study site. Urine: (t1= week 1 and t2= week 2) One voided sample of urine will be collected at the study site. One dipstick strip is used to measure ketones. Vital signs: (t0 =baseline, t1= week 1 and t2= week 2) Pulse rate and blood pressure were measured after 5 minutes of rest in the seated position at the outpatient clinic. Anthropometric measurements: (t0 =baseline, t1= week 1 and t2= week 2) Height and body weight were obtained at the outpatient clinic; patients will be weighted clothed without shoes. Body composition will be assessed at the outpatient clinic by Body Impedance Assessment. Waist-to-hip ratio were measured as follows. The waist was defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The hip was defined as the wides circumference over the great trochanters. Circumferences were measured with the subjects in the standing position using flexible tape measure and maintaining close contact with the skin without compression of underlying tissues. One questionnaire: (t1= week 1 and t2= week 2) will be filled out at the outpatient clinic(*Vragenlijst gebruik en e | — |
Countries
Netherlands
Outcome results
None listed